Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial

The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a... Background: Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. Methods: A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients’ level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients’ level of pain after the procedure, anxiety and satisfaction of patient and doctor. Results: No positive effect of music on patients’ perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. Conclusions: This study showed no positive effect of music on patients’ level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. Trial registration: Dutch Trial Register, NTR4924 Keywords: Pain, Anxiety, Music, Office procedures, Hysteroscopy, Colposcopy Background demonstrated a significant reduction of 0.4 points on a Today, office procedures in gynaecology are widely used 0–10 scale, which is of doubtful clinical importance [9]. to diagnose and directly treat gynaecological abnormalities Research on this topic in gynaecology is also not conclu- [1–3]. However, pain and anxiety remain problems that sive. The meta-analysis of Wang et al. suggested a positive may impede the procedure and can contribute to a nega- effect of music regarding pain, anxiety and satisfaction for tive experience for the patient [4–8]. patients undergoing endoscopic surgery. For patients Listening to music could be an easy and non-invasive undergoing colposcopy, no effect was found [10]. This way to decrease pain and anxiety. However, the litera- result is the sum of two randomized controlled trials ture is not clear about the efficacy of music therapy. with contradictory results regarding the impact of Music for pain relief of any type was previously exam- music in office colposcopy, with no effect versus an ined in a review including 31 studies. The studies almost 2 point decrease in pain measured by the VAS showed a high variation in the results. Pooled data (0–10) in favour of music therapy [7, 11, 12]. Only one article could be found on the effect of music dur- ing office hysteroscopy. Angioli et al. showed a posi- tive effect of the use of music with a reduction of pain and anxiety [13]. * Correspondence: N.mak@alumni.maastrichtuniversity.nl The effect of music in gynaecological office procedures Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands on satisfaction of patients is less frequently examined. Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Mak et al. Gynecological Surgery (2017) 14:14 Page 2 of 8 Danhauer et al. found no effect [11]. Other studies in of- office procedure more difficult (e.g., cervical conization, fice gynaecology did not examine the efficacy of music on Manchester Fothergill). satisfaction of patients [12, 13]. The satisfaction of the doctor is not described in any of these articles [11–13]. Outcomes However, music can have a negative influence on task The primary outcome was the experience of pain during performance and level of irritation of the surgeon in lap- the procedure, measured with the VAS on a 0–100 mm aroscopic surgery [14, 15]. Therefore, this satisfaction of scale. The measurement took place during biopsy or the doctor should not be ignored. LLETZ in the group of women undergoing colposcopy Previous research on the effect of music in gynaeco- or during the passage of the internal ostium in the group logical office procedures was not blinded for patients of women undergoing hysteroscopy. Secondary out- or doctors, meaning there was a risk of bias [11–13]. comes were heart rate and anxiety during the procedure, Moreover, other interventions to decrease the patient’s pain after the procedure and satisfaction of patient and discomfort, such as verbal communication between doctor. The heart rate was measured by using a pulse patient and doctor or nurse, are not mentioned or are oximeter. The highest heart rate was used which was excluded in previous studies [11–13]. Positive interac- measured at the same time as the VAS during the tions between patient and doctor or nurse may inter- procedure. act with pain and anxiety and such interaction is often Anxiety of the patient was measured using the vali- used in daily practice. The use of local anaesthetics, dated Dutch version of the State-Trait Anxiety Inven- the use of information leaflets and the use of video- tory (STAI) before and after the procedure. State scopy are all methods used to improve patients’ ex- anxiety and trait anxiety were both assessed by 20 perience [3,6,7,16]. items with scores ranging from 20 to 80, with higher We can conclude from previous research that a large scores indicating greater levels of anxiety. Satisfaction discrepancy exists in the efficacy of music in the reduc- of patient and doctor was described using a scale of 1 tion of pain and anxiety. Research on the effect of music to 5. In addition, the participants were asked if they on the satisfaction of patient and doctor is rare. Previous would recommend the procedure in this setting to a research is possibly biased and does not answer the friend. The doctor was asked if he or she would like to question of whether music is beneficial for patients and repeat the procedure in the same setting. Further, if doctors in daily practice. The aim of this study is to applicable, the doctor was asked for the level of irrita- demonstrate the complementary value of music in gy- tion regarding the music. Data and scores were re- naecological office procedures on patients’ level of pain, ported in a case report form (CRF) and subsequently anxiety and satisfaction during and after the procedure imported inthedatabasebyone personandcontrolled in daily practice. The experience of the doctor will be by another person. Excel was used as database. evaluated as well. Procedure Methods The researchers informed the patients who met the Trial design inclusion criteria in advance of their hospital visit. Between October 2014 and July 2016, a single-blind The eligible participants were told that they would prospective randomized controlled superiority trial was participate in a study of pain relief during office pro- performed at the Department of Obstetrics and Gynae- cedures. In order to perform single-blind testing, they cology in the Máxima Medical Centre in Veldhoven, the were not informed about the role of music. After giv- Netherlands. The trial was approved by the Medical Ethics ing informed consent, the following information was Committee of the hospital (Study number 2014–28) and collected from all participants before the procedure: was registered in the Dutch Trial Register under trial ID age, height, weight, drug use, use of painkillers before number NTR4924. the procedure, parity, intensity of dysmenorrhoea and expected pain of the procedure both measured by the Participants VAS. Participants were asked to arrive 15 min before All patients who referred to the outpatient clinic for a their appointment to fill out the questionnaire with hysteroscopy or colposcopy were considered for inclu- baseline characteristics and the STAI. Furthermore, sion. Inclusion criteria were Dutch-speaking women, of the participant’s heart rate was measured before the at least 18 years of age, planned for an office hysteros- procedure. copy or colposcopy with biopsy or large loop excision of The researchers randomized participants to the music the transformation zone (LLETZ). Exclusion criteria group or control group. Stratification for hysteroscopy were hearing impairments, blindness and known ana- and colposcopy took place. Sealed numbered opaque tomical characteristics that may make performing the envelopes were used for randomization. Participants who Mak et al. Gynecological Surgery (2017) 14:14 Page 3 of 8 were randomized for the music group could choose and the STAI. The doctor was asked for the degree of between three types of music: pop, classical music and spa difficulty of the procedure. To achieve a smooth imple- music. An iPod with speakers was used to play the music mentation of the study without influencing the standard instead of headphones to maintain a good communica- procedure, a pilot study with ten participants was con- tion. The volume of the speakers could be adjusted by the ducted before the start of this study to train the staff. doctor or researchers in a way so that the music was audible without disturbing the interaction between the Statistical methods participant and doctor or nurse. A gynaecologist or a resi- Based on the previous research, a decrease of 20 mm on dent performed the procedure. The experience of pain in the VAS scale was expected when using music during VAS and participant’s heart rate were measured during the procedure [12, 13]. A sample size of 38 participants the procedure. for each arm was calculated for both hysteroscopy and To determine whether or not music is beneficial for pa- colposcopy based on the power analysis with a power of tients and doctors in daily practice, other contemporary 0.90, a 5% significance level and an expected loss to interventions to decrease patients’ discomfort remained follow-up of 5%. unchanged with respect to the standard procedure. These The Shapiro-Wilk test was used to test the normality of include the use of information leaflets, the advice to use a the data. Depending on this result, the t test or the Mann- painkiller before the procedure, the communication be- Whitney U test was used. Categorical data were tested tween patient and doctor, the emotional support by a using the chi-square test. If there was a statistical signifi- nurse and the use of videoscopy during the procedure. A cant difference in base characteristics between the music cervical block for patients undergoing a colposcopy was group and the control group, linear regression was used to used if indicated according to the doctor. test for confounding. In case of confounding, the primary After the procedure, participants were asked again to fill outcome was calculated with correction of these variables out a questionnaire regarding their level of satisfaction by linear regression. For all outcomes, the intention-to- Fig. 1 Hysteroscopy: flow chart patient inclusion Mak et al. Gynecological Surgery (2017) 14:14 Page 4 of 8 treat analysis was used. In addition, a per-protocol analysis anxiety during the procedure, pain after the procedure was performed for the primary outcome. All statistical and satisfaction of patient and doctor (p > .05) (Table 2). analyses were performed using IBM SPSS Statistics for No complications occurred. Windows (version 21.0, Armonk: NY, IBM Corp). In three cases (8%) in the music group, the doctor was (very) dissatisfied. One doctor reported that this was caused by the music, which was not a genre he or she Results enjoys. In another procedure, the doctor mentioned the Hysteroscopy dissatisfaction was correlated with the difficulty of the Eighty-two participants were included, 39 participants in procedure. The reason for the last case was not reported. the music group and 43 participants in the control group. In two cases (5%), the doctor in the music group men- One participant in the control group received a saline in- tioned that he or she did not want to repeat the procedure fusion sonohysterography (SIS) only and was excluded in the same setting. The disturbing music was the reason from further analyses. Thus, 81 participants (39 in the for one of these two cases. The most popular music choice music group and 42 in the control group) were considered in the music group was pop music (58%), followed by clas- for the statistical analyses. Two participants from the sical music (21%) and spa music (21%). music group did not receive music during the passage of Besides an intention-to-treat analysis, a per-protocol the internal ostium of the cervix, due to a technical prob- analysis was performed only for the primary outcome lem with the iPod (Fig. 1). because two participants from the control group did not Baseline characteristics are shown in Table 1. These receive music during the passage of the internal ostium. characteristics were similar for both groups. No statis- Again, no difference was found (59.2 (24.3) mm vs. 50.0 tical significance was found for pain during the proced- (27.7) mm, p = .154). ure between the music group and the control group Table 2 Hysteroscopy: results (57.1 (25.7) mm vs. 51.6 (27.1) mm, p = .382). Secondary Music group Control group P value outcomes were also similar, including heart rate and N =39 N =42 Pain during procedure 57.1 (25.7) 51.6 (27.1) 0.382 (mm VAS) Table 1 Hysteroscopy: patient characteristics Pain after procedure 29.2 (25.9) 32.2 (27.8) 0.715 Music group Control group (mm VAS) N =39 N =42 Heart rate during 82.6 (14.0) 83.3 (13.7) 0.833 Age (y) 45.4 (13.2) 45.2 (15.0) procedure (bpm) Height (m) 1.67 (0.07) 1.66 (0.07) Patient recommend a 97 93 0.617 Weight (kg) 77.3 (20.7) 73.2 (14.5) friend (%) Body mass index 27.6 (7.6) 26.7 (6.4) Patient satisfaction (%) 0.958 Dysmenorrhea (mm VAS) 38.7 (31.4) 41.0 (26.7) Very satisfied 59 62 Expected pain (mm VAS) 51.2 (21.3) 54.6 (22.9) Satisfied 31 31 Heart rate before procedure (bpm) 80.4 (11.1) 78.6 (13.2) Normal 8 5 Use of a painkiller (%) 82 88 Dissatisfied 2 2 Difficulty of procedure (%) Very dissatisfied 0 0 Very easy 27 37 Doctor refuses same 5 2 0.610 procedure in same Easy 40 23 setting for this patient (%) Normal 19 34 Satisfaction doctor (%) 0.165 Difficult 11 3 Very satisfied 50 60 Very difficult 3 3 Satisfied 29 20 Intervention (%) Normal 13 5 Diagnostic 23 31 Dissatisfied 0 10 Biopsies 23 21 Very dissatisfied 8 5 Therapeutic 54 48 Complications (%) 0 0 NS Diameter 5.5 mm Hysteroscope (%) 67 74 STAI 1 score after procedure 34.1 (8.6) 35.9 (9.6) 0.491 STAI 1 score before procedure 40.7 (13.0) 42.6 (12.5) STAI 1 score difference 6.3 (12.8) 5.7 (10.9) 0.820 STAI 2 score 34.0 (8.0) 36.0 (10.5) Data are expressed as mean (SD) or percentage Data are expressed as mean (SD) or percentage NS not significant Mak et al. Gynecological Surgery (2017) 14:14 Page 5 of 8 Colposcopy patient and doctor (p > .05) (Table 4). No complica- Eighty participants were included, 42 participants in the tions occurred. music group and 38 participants in the control group. In In five cases in the music group (12%), the doctor no- each group, 3 participants did not meet the inclusion ticed he or she was disturbed by the music during the criteria because no biopsy or LLETZ was performed dur- procedure. In three of these cases, the volume of the ing colposcopy. These participants were excluded from music was too loud; in one case, the music was not of further analyses. Therefore, 74 participants (39 music the genre preferred by the doctor; and in the last case, group and 35 control group) were considered for statis- no explanation was given. In one case in the music tical analyses. One participant of the music group re- group, the doctor was dissatisfied without mentioning a fused music during the procedure (Fig. 2). reason (3%). The most popular music genre chosen in Baseline characteristics are shown in Table 3. A signifi- the music group was pop music (67%), followed by cant difference between the groups was found for dys- classical music (18%) and spa music (15%). menorrhoea (24.1 (24.8) mm vs. 38.2 (22.9) mm, In addition to the intention-to-treat analysis, a per- p = .013) and the performance of a cervical block (72 vs. protocol analysis was performed only for the primary 47%, p = .031). For all other characteristics, no difference outcome because one participant refused music. Still no was found (p > .05). No significant difference was found difference was found in pain between the groups (33.3 for pain during the procedure between the music group (24.0) mm vs. 30.7 (27.4) mm, p = .579). Dysmenorrhoea and control group (32.4 (24.3) mm vs. 31.6 (27.3) mm, and performance of a cervical block were both different p = .826). Secondary outcomes were also similar, in- between the groups (Table 3). After performing a linear cluding heart rate and anxiety during the procedure, regression, we concluded that both variables are con- pain after the procedure and satisfaction of the founders for the primary outcome. Correction of these Fig. 2 Colposcopy: flow chart patient inclusion Mak et al. Gynecological Surgery (2017) 14:14 Page 6 of 8 Table 3 Colposcopy: patient characteristics Table 4 Colposcopy: results Music group Control group Music group Control group P value N =39 N =35 N =39 N =35 Age (y) 38.8 (8.3) 38.9 (10.7) Pain during procedure 32.4 (24.3) 31.6 (27.3) 0.826 (mm VAS) Height (m) 1.69 (0.06) 1.70 (0.06) Pain after procedure 23.6 (21.5) 27.6 (25.6) 0.637 Weight (kg) 69.0 (13.3) 69.6 (17.8) (mm VAS) Body mass index 24.0 (4.1) 24.1 (6.1) Heart rate during 82.4 (16.1) 82.7 (15.1) 0.929 procedure (bpm) Dysmenorrhea (mm VAS) 24.1 (24.8) 38.2 (22.9) Patient recommends 95 88 0.408 Expected pain (mm VAS) 43.1 (23.9) 49.4 (22.1) a friend (%) Heart rate before procedure 78.2 (15.1) 82.1 (14.8) Patient satisfaction (%) 0.571 (bpm) Very satisfied 77 79 Use of a painkiller (%) 8 9 Satisfied 15 15 Use of cervical block (%) 72 47 Normal 3 3 Pap smear score (PAP) (%) Dissatisfied 5 0 PAP 2 29 26 Very dissatisfied 0 3 PAP 3a 48 48 Doctor refuses same 5 3 1.000 PAP 3b 23 26 procedure in same Colposcopic impression (%) setting for this patient (%) Normal 6 7 Satisfaction doctor (%) 0.769 Low grade 47 64 Very satisfied 74 79 High grade 44 29 Satisfied 18 15 Carcinoma 3 0 Normal 5 6 Difficulity of procedure (%) Dissatisfied 3 0 Very easy 47 65 Very dissatisfied 0 0 Easy 29 26 Complications (%) 0 0 NS Normal 18 0 STAI 1 score after 38.4 (15.3) 35.5 (9.6) 0.584 procedure Difficult 3 6 STAI 1 score difference 3.8 (14.4) 7.5 (10.2) 0.463 Very difficult 3 3 Data are expressed as mean (SD) or percentage Intervention (%) NS not significant Cold biopsy 28 54 Hot biopsy 3 0 was evaluated as well. We found no positive effect of music, neither in hysteroscopy nor in colposcopy. LLETZ 69 46 STAI 1 score before 42.1 (12.3) 42.6 (8.7) Strength and limitations procedure To our knowledge, this is the first randomized controlled STAI 2 score 34.9 (10.1) 34.3 (7.9) trial investigating the effect of music in gynaecological of- Data are expressed as mean (SD) or percentage fice procedures taking into account the opinion of the doc- tor. Moreover, we explored the additional effect of music in variables for pain during the procedure resulted in the daily practice. Methods that were already used to improve same conclusion, i.e. no statistical significance between patients’ experience remained unchanged with respect to the two groups (p = .806). A per-protocol analysis with the standard procedure to increase external validity. An- correction for these two confounders showed the same other asset of this study is its use of single-blind testing. result (p = .563). The participants in this study were not informed about the role of musicinthisstudy;theywereonlyinformedabout Discussion the goal to improve patients’ experience during office pro- Main findings cedures in a non-invasive manner with a controlled trial. The aim of this study was to measure the additional effect This is unique in comparison to other studies. of music in gynaecological office procedures on patients’ A limitation of this study is that waiting time and dur- level of pain, anxiety and satisfaction during and after the ation of the procedure were not examined. Waiting time procedure in daily practice. The experience of the doctor can possibly change the anxiety and pain level of the patient Mak et al. Gynecological Surgery (2017) 14:14 Page 7 of 8 and prolonged duration of the procedure can increase the of Danhauer et al., iPods with speakers were used in dissatisfaction of the patient and the doctor. Another limi- our study, giving the same result. tation is the difference in experience between the doctors. The potential positive effect of music may have been In both groups, hysteroscopy and colposcopy, the doctors overpowered by the multimodal approach in our study. consisted of both gynaecologists and residents. According The use of information leaflets, analgesics, the inter- to the literature, pain scores can be lower when an experi- action between patient and doctor, a nurse to offer enced doctor performs the procedure [17]. iPod speakers emotional support and the use of videoscopy are all were used to play the music which prevented double-blind used in daily practice. For that reason, they remained testing. However, during the pilot study, headphones turned unchanged with respect to the standard procedure in out to impede the interaction between patient and doctor. this trial. Information leaflets increase the patient’s For this reason, headphones were waived. knowledge and therefore could improve the patient’sex- perience [7]. The value of oral analgesics is limited [3, 18], Interpretation but local anaesthesia could be effective at achieving pain Despite randomization, we found a difference between relief [3]. A monitor for videocolposcopy, allowing the pa- dysmenorrhoea and the use of a cervical block between tient to view the procedure, reduces patient anxiety and the groups in the patients receiving a colposcopy. The pain during routine colposcopic examination [16]. Finally, women in the music group had less dysmenorrhoea, but active emotional support can reduce pain [19]. more of them received cervical anaesthesia (Table 3). Another explanation for our results, which is possibly Significantly, less dysmenorrhoea could imply a higher associated with the multimodal approach described pain threshold in that group which may confound the above, is the relatively low pain score in our trial. The primary outcome. The difference in cervical anaesthesia control group in the colposcopy group showed lower could be explained by the difference in intervention be- scores in comparison with the trials of Chan et al. and tween the groups (p = .056). Women who underwent Danhauer et al., namely 31.6 in this trial versus 50.3 and cold biopsies did not receive a cervical block in contrast 51.7 in the other trials. The power analysis and expected with electrical biopsies and LLETZ. The cervical block pain reduction in this trial were based on these results given in this trial consists of an anaesthetic (articaine) and from previous trials. Moreover, a score of VAS 40 is fre- a vasoconstrictor (epinephrine). According to Gajjar et al., quently used in the literature as a pain threshold [17, 20, receiving local anaesthetics and a vasoconstrictor could 21]. Therefore, with an initial pain score lower than 40, possibly reduce pain experience in women undergoing the clinical relevance of pain relief is doubtful. Thus, we colposcopy. Therefore, the difference in dysmenorrhoea believe that our multimodal approach already greatly im- and the use of a cervical block between the groups is rele- proves patients’ experience and possibly hereby camou- vant. For this reason, a correction was performed for these flages the potential effect of music. confounders. Still, no difference was found between the We found no difference in the satisfaction of the doc- music group and control group. Thus, the result remained tors between the music group and the control group for unchanged. both hysteroscopy and colposcopy. However, some doc- Previous research in music for pain relief showed a large tors mentioned that they were disturbed by the music; difference in results with high heterogeneity in studies as one case in the hysteroscopy group (3%) and five cases described in the systematic review of Cepeda et al. A posi- in the colposcopy group (12%). The difference between tive effect of music in gynaecological office procedures the two groups can be explained by the different doctors was found in randomized controlled trials performed by performing a hysteroscopy or a colposcopy. Despite the Angioli et al. and Chan et al. However, another random- fact that the volume could be adjusted, the reasons they ized controlled trial by Danhauer et al. found no difference mentioned for their irritation were the volume of the between the music group and the control group for pain, music and the fact that it was not the kind of music they anxiety or satisfaction. These results are similar to the enjoy. Therefore, perhaps the use of more neutral music results in this current trial. Danhauer et al. suggest that set at a lower volume would satisfy these doctors. Unfor- their results are probably different from the results of tunately, we did not examine the music preferences of the two previously mentioned trials because of the lim- the doctors. ited choice of five music genres, the number of physi- cians and the difficulty in hearing what the doctor was Conclusion saying because of the headphones. However, according In conclusion, our study showed no positive effect of music to a systematic review, the decline in pain intensity is regarding pain, anxiety or satisfaction for office hysteros- similar in studies wherein patients selected the type of copy and colposcopy. We believe a multimodal approach music and in those wherein patients did not select their should be used to decrease patient distress in terms of pain music[9].Instead of theheadphonesusedinthe trial and anxiety, with or without music. Mak et al. Gynecological Surgery (2017) 14:14 Page 8 of 8 Funding 12. Chan YM, Lee PW, NG TY, et al (2003) The use of music to reduce anxiety This study did not receive any funding. for patients undergoing colposcopy: a randomised trial. Gynecol Oncol 91(1):213–217 Authors’ contributions 13. Angioli R, De Cicco Nardone C, Plotti F, et al. (2014) Use of music to reduce NM contributed to the protocol development, data collection, data anxiety during office hysteroscopy: prospective randomized trial. J Minim analysis and manuscript writing. IMAR contributed to the data collection Invasive Gynecol 21(3):454–459. doi:10.1016/j.jmig.2013.07.020 and manuscript writing. SAS contributed to the protocol development and 14. Pluyter JR, Buzink SN, Rutkowski AF, Jakimowics JJ (2010) Do absorption and data collection. EHMNW contributed to the protocol development, data realistic distraction influence performance of component task surgical collection and manuscript writing. JWMM contributed to the manuscript procedure? Surg Endosc 24(4):902–907. doi:10.1007/s00464-009-0689-7 writing. MYB contributed to the protocol development and manuscript 15. Way TJ, Long A, Weihing J, et al (2013) Effect of noise on auditory writing. All authors read and approved the final manuscript. processing in the operating room. J Am Coll Surg 216(5):933–938. doi:10.1016/j.jamcollsurg.2012.12.048 Ethics approval and consent to participate 16. Walsh JC, Curtis R, Mylotte M (2004) Anxiety levels in women attending a The trial was approved by the Medical Ethics Committee of the hospital colposcopy clinic: a randomised trial of an educational intervention using (Study number 2014–28). The committee determined that this study did not video colposcopy. Patient Educ Couns 55(2):247–251 belong to the scope of the medical research involving human subjects act. 17. Campo R, Molinas CR, Rombouts L et al (2005) Prospective multicentre randomized controlled trial to evaluate factors influencing the success rate Consent for publication of office diagnostic hysteroscopy. Hum Reprod 20(1):258–263 Informed consent was obtained from all individual participants included in 18. Tam WH, Yuen PM (2001) Use of diclofenac as an analgesic in outpatient the study. hysteroscopy: a randomized, double-blind, placebo-controlled study. Fertil Steril 76(5):1070–1072 Competing interests 19. Ireland LD, Allen RH (2016) Pain management for gynecologic procedures The authors declare that they have no competing interests. in the office. Obstet Gynecol Surv 71(2):89–98. doi:10.1097/OGX. 20. Cepeda MS, Africano JM, Polo R et al (2003) What decline in pain intensity Publisher’sNote is meaningful to patients with acute pain? Pain 105(1–2):151–157 Springer Nature remains neutral with regard to jurisdictional claims in 21. Litta P, Cosmi E, Saccardi C et al (2008) Outpatient operative polypectomy published maps and institutional affiliations. using a 5 mm-hysteroscope without anaesthesia and/or analgesia: advantages and limits. Eur J Obstet Gynecol Reprod Biol 139(2):210–214. doi: Author details 10.1016/j.ejogrb.2007.11.008 Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands. Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo, The Netherlands. Department of Obstetrics and Gynaecology, Rode Kruis Hospital, Beverwijk, The Netherlands. Department of Obstetrics and Gynaecology, GROW—School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands. Received: 22 March 2017 Accepted: 26 July 2017 References 1. Bettocchi S, Nappi L, Ceci O, Selvaggi L (2004) Office hysteroscopy. Obstet Gynecol Clin N Am 31:641–654 2. Nagele F, OÇonnor H, Davies A, et al (1996) 2500 Outpatient diagnostic hysteroscopies. Obstet Gynecol 88(1):87–92 3. Gajjar K, Martin-Hirsch PPL, Bryant A, Owens GL (2016) Pain relief for women with cervical intraepithelial neoplasia undergoing colposcopy treatment. Cochrane Database Syst Rev 18;7:CD006120.doi:10.1002/14651858.CD006120 4. Marteau TM, Walker P, Giles J et al (1990) Anxieties in women undergoing colposcopy. BJOG 97:859–861 5. Gambadauro P, Navaratnarajah R, Carli V (2015) Anxiety at outpatient hysteroscopy. Gynec Surg 12(3):189–196 6. Ahmad G, O’Flynn H, Attarbashi S, et al (2010) Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev 10;(11):CD007710. doi: 10.1002/ 14651858.CD007710 7. Galaal K, Bryant A, Deane KHO et al (2011) Interventions for reducing anxiety in women undergoing colposcopy. Cochrane Database Syst Rev 7(12):CD006013. doi:10.1002/14651858.CD006013 8. De Carvalho Schettini JA, Ramos de Amorim MM, Ribeiro Costa AA, Albuquerque Neto LC et al (2007) Pain evaluation in outpatients undergoing diagnostic anesthesia-free hysteroscopy in a teaching hospital: a cohort study. J Minim Invasive Gynecol 14(6):729–735 9. Cepeda MS, Carr DB, Lau J, Alvarez H (2006) Music for pain relief. Cochrane Database Syst Rev 19;(2):CD004843 10. Wang MW, Zhang LY, Zhang YL, et al (2014) Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med 15(10):1786–1794. doi:10.1111/pme.12514 11. Danhauer SC, Marler B, Rutherford CA et al (2007) Music or guided imagery for women undergoing colposcopy: a randomized controlled study of effects on anxiety, perceived pain, and patient satisfaction. J Low Genit Tract Dis 11(1):39–45 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Gynecological Surgery Springer Journals

The effect of music in gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial

Download PDF
8 pages

Loading next page...
 
/lp/springer_journal/the-effect-of-music-in-gynaecological-office-procedures-on-pain-qLtHiYYKQL

References (24)

Publisher
Springer Journals
Copyright
Copyright © 2017 by The Author(s).
Subject
Medicine & Public Health; Gynecology; Minimally Invasive Surgery; Surgical Oncology; Obstetrics/Perinatology/Midwifery; Reproductive Medicine; Interventional Radiology
ISSN
1613-2076
eISSN
1613-2084
DOI
10.1186/s10397-017-1016-2
Publisher site
See Article on Publisher Site

Abstract

Background: Pain can interfere with office procedures in gynaecology. The aim of this study is to measure the positive effect of music in gynaecological office procedures. Methods: A randomized controlled trial was performed between October 2014 and January 2016. Women scheduled for an office hysteroscopy or colposcopy were eligible for randomization in the music group or control group. Stratification for hysteroscopy and colposcopy took place. The primary outcome is patients’ level of pain during the procedure measured by the visual analogue scale (VAS). Secondary outcomes include patients’ level of pain after the procedure, anxiety and satisfaction of patient and doctor. Results: No positive effect of music on patients’ perception of pain during the procedure was measured, neither for the hysteroscopy group (57 mm vs. 52 mm) nor for the colposcopy group (32 mm vs. 32 mm). Secondary outcomes were also similar for both groups. Conclusions: This study showed no positive effect of music on patients’ level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. We believe a multimodal approach has to be used to decrease patient distress in terms of pain and anxiety, with or without music. Trial registration: Dutch Trial Register, NTR4924 Keywords: Pain, Anxiety, Music, Office procedures, Hysteroscopy, Colposcopy Background demonstrated a significant reduction of 0.4 points on a Today, office procedures in gynaecology are widely used 0–10 scale, which is of doubtful clinical importance [9]. to diagnose and directly treat gynaecological abnormalities Research on this topic in gynaecology is also not conclu- [1–3]. However, pain and anxiety remain problems that sive. The meta-analysis of Wang et al. suggested a positive may impede the procedure and can contribute to a nega- effect of music regarding pain, anxiety and satisfaction for tive experience for the patient [4–8]. patients undergoing endoscopic surgery. For patients Listening to music could be an easy and non-invasive undergoing colposcopy, no effect was found [10]. This way to decrease pain and anxiety. However, the litera- result is the sum of two randomized controlled trials ture is not clear about the efficacy of music therapy. with contradictory results regarding the impact of Music for pain relief of any type was previously exam- music in office colposcopy, with no effect versus an ined in a review including 31 studies. The studies almost 2 point decrease in pain measured by the VAS showed a high variation in the results. Pooled data (0–10) in favour of music therapy [7, 11, 12]. Only one article could be found on the effect of music dur- ing office hysteroscopy. Angioli et al. showed a posi- tive effect of the use of music with a reduction of pain and anxiety [13]. * Correspondence: N.mak@alumni.maastrichtuniversity.nl The effect of music in gynaecological office procedures Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands on satisfaction of patients is less frequently examined. Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Mak et al. Gynecological Surgery (2017) 14:14 Page 2 of 8 Danhauer et al. found no effect [11]. Other studies in of- office procedure more difficult (e.g., cervical conization, fice gynaecology did not examine the efficacy of music on Manchester Fothergill). satisfaction of patients [12, 13]. The satisfaction of the doctor is not described in any of these articles [11–13]. Outcomes However, music can have a negative influence on task The primary outcome was the experience of pain during performance and level of irritation of the surgeon in lap- the procedure, measured with the VAS on a 0–100 mm aroscopic surgery [14, 15]. Therefore, this satisfaction of scale. The measurement took place during biopsy or the doctor should not be ignored. LLETZ in the group of women undergoing colposcopy Previous research on the effect of music in gynaeco- or during the passage of the internal ostium in the group logical office procedures was not blinded for patients of women undergoing hysteroscopy. Secondary out- or doctors, meaning there was a risk of bias [11–13]. comes were heart rate and anxiety during the procedure, Moreover, other interventions to decrease the patient’s pain after the procedure and satisfaction of patient and discomfort, such as verbal communication between doctor. The heart rate was measured by using a pulse patient and doctor or nurse, are not mentioned or are oximeter. The highest heart rate was used which was excluded in previous studies [11–13]. Positive interac- measured at the same time as the VAS during the tions between patient and doctor or nurse may inter- procedure. act with pain and anxiety and such interaction is often Anxiety of the patient was measured using the vali- used in daily practice. The use of local anaesthetics, dated Dutch version of the State-Trait Anxiety Inven- the use of information leaflets and the use of video- tory (STAI) before and after the procedure. State scopy are all methods used to improve patients’ ex- anxiety and trait anxiety were both assessed by 20 perience [3,6,7,16]. items with scores ranging from 20 to 80, with higher We can conclude from previous research that a large scores indicating greater levels of anxiety. Satisfaction discrepancy exists in the efficacy of music in the reduc- of patient and doctor was described using a scale of 1 tion of pain and anxiety. Research on the effect of music to 5. In addition, the participants were asked if they on the satisfaction of patient and doctor is rare. Previous would recommend the procedure in this setting to a research is possibly biased and does not answer the friend. The doctor was asked if he or she would like to question of whether music is beneficial for patients and repeat the procedure in the same setting. Further, if doctors in daily practice. The aim of this study is to applicable, the doctor was asked for the level of irrita- demonstrate the complementary value of music in gy- tion regarding the music. Data and scores were re- naecological office procedures on patients’ level of pain, ported in a case report form (CRF) and subsequently anxiety and satisfaction during and after the procedure imported inthedatabasebyone personandcontrolled in daily practice. The experience of the doctor will be by another person. Excel was used as database. evaluated as well. Procedure Methods The researchers informed the patients who met the Trial design inclusion criteria in advance of their hospital visit. Between October 2014 and July 2016, a single-blind The eligible participants were told that they would prospective randomized controlled superiority trial was participate in a study of pain relief during office pro- performed at the Department of Obstetrics and Gynae- cedures. In order to perform single-blind testing, they cology in the Máxima Medical Centre in Veldhoven, the were not informed about the role of music. After giv- Netherlands. The trial was approved by the Medical Ethics ing informed consent, the following information was Committee of the hospital (Study number 2014–28) and collected from all participants before the procedure: was registered in the Dutch Trial Register under trial ID age, height, weight, drug use, use of painkillers before number NTR4924. the procedure, parity, intensity of dysmenorrhoea and expected pain of the procedure both measured by the Participants VAS. Participants were asked to arrive 15 min before All patients who referred to the outpatient clinic for a their appointment to fill out the questionnaire with hysteroscopy or colposcopy were considered for inclu- baseline characteristics and the STAI. Furthermore, sion. Inclusion criteria were Dutch-speaking women, of the participant’s heart rate was measured before the at least 18 years of age, planned for an office hysteros- procedure. copy or colposcopy with biopsy or large loop excision of The researchers randomized participants to the music the transformation zone (LLETZ). Exclusion criteria group or control group. Stratification for hysteroscopy were hearing impairments, blindness and known ana- and colposcopy took place. Sealed numbered opaque tomical characteristics that may make performing the envelopes were used for randomization. Participants who Mak et al. Gynecological Surgery (2017) 14:14 Page 3 of 8 were randomized for the music group could choose and the STAI. The doctor was asked for the degree of between three types of music: pop, classical music and spa difficulty of the procedure. To achieve a smooth imple- music. An iPod with speakers was used to play the music mentation of the study without influencing the standard instead of headphones to maintain a good communica- procedure, a pilot study with ten participants was con- tion. The volume of the speakers could be adjusted by the ducted before the start of this study to train the staff. doctor or researchers in a way so that the music was audible without disturbing the interaction between the Statistical methods participant and doctor or nurse. A gynaecologist or a resi- Based on the previous research, a decrease of 20 mm on dent performed the procedure. The experience of pain in the VAS scale was expected when using music during VAS and participant’s heart rate were measured during the procedure [12, 13]. A sample size of 38 participants the procedure. for each arm was calculated for both hysteroscopy and To determine whether or not music is beneficial for pa- colposcopy based on the power analysis with a power of tients and doctors in daily practice, other contemporary 0.90, a 5% significance level and an expected loss to interventions to decrease patients’ discomfort remained follow-up of 5%. unchanged with respect to the standard procedure. These The Shapiro-Wilk test was used to test the normality of include the use of information leaflets, the advice to use a the data. Depending on this result, the t test or the Mann- painkiller before the procedure, the communication be- Whitney U test was used. Categorical data were tested tween patient and doctor, the emotional support by a using the chi-square test. If there was a statistical signifi- nurse and the use of videoscopy during the procedure. A cant difference in base characteristics between the music cervical block for patients undergoing a colposcopy was group and the control group, linear regression was used to used if indicated according to the doctor. test for confounding. In case of confounding, the primary After the procedure, participants were asked again to fill outcome was calculated with correction of these variables out a questionnaire regarding their level of satisfaction by linear regression. For all outcomes, the intention-to- Fig. 1 Hysteroscopy: flow chart patient inclusion Mak et al. Gynecological Surgery (2017) 14:14 Page 4 of 8 treat analysis was used. In addition, a per-protocol analysis anxiety during the procedure, pain after the procedure was performed for the primary outcome. All statistical and satisfaction of patient and doctor (p > .05) (Table 2). analyses were performed using IBM SPSS Statistics for No complications occurred. Windows (version 21.0, Armonk: NY, IBM Corp). In three cases (8%) in the music group, the doctor was (very) dissatisfied. One doctor reported that this was caused by the music, which was not a genre he or she Results enjoys. In another procedure, the doctor mentioned the Hysteroscopy dissatisfaction was correlated with the difficulty of the Eighty-two participants were included, 39 participants in procedure. The reason for the last case was not reported. the music group and 43 participants in the control group. In two cases (5%), the doctor in the music group men- One participant in the control group received a saline in- tioned that he or she did not want to repeat the procedure fusion sonohysterography (SIS) only and was excluded in the same setting. The disturbing music was the reason from further analyses. Thus, 81 participants (39 in the for one of these two cases. The most popular music choice music group and 42 in the control group) were considered in the music group was pop music (58%), followed by clas- for the statistical analyses. Two participants from the sical music (21%) and spa music (21%). music group did not receive music during the passage of Besides an intention-to-treat analysis, a per-protocol the internal ostium of the cervix, due to a technical prob- analysis was performed only for the primary outcome lem with the iPod (Fig. 1). because two participants from the control group did not Baseline characteristics are shown in Table 1. These receive music during the passage of the internal ostium. characteristics were similar for both groups. No statis- Again, no difference was found (59.2 (24.3) mm vs. 50.0 tical significance was found for pain during the proced- (27.7) mm, p = .154). ure between the music group and the control group Table 2 Hysteroscopy: results (57.1 (25.7) mm vs. 51.6 (27.1) mm, p = .382). Secondary Music group Control group P value outcomes were also similar, including heart rate and N =39 N =42 Pain during procedure 57.1 (25.7) 51.6 (27.1) 0.382 (mm VAS) Table 1 Hysteroscopy: patient characteristics Pain after procedure 29.2 (25.9) 32.2 (27.8) 0.715 Music group Control group (mm VAS) N =39 N =42 Heart rate during 82.6 (14.0) 83.3 (13.7) 0.833 Age (y) 45.4 (13.2) 45.2 (15.0) procedure (bpm) Height (m) 1.67 (0.07) 1.66 (0.07) Patient recommend a 97 93 0.617 Weight (kg) 77.3 (20.7) 73.2 (14.5) friend (%) Body mass index 27.6 (7.6) 26.7 (6.4) Patient satisfaction (%) 0.958 Dysmenorrhea (mm VAS) 38.7 (31.4) 41.0 (26.7) Very satisfied 59 62 Expected pain (mm VAS) 51.2 (21.3) 54.6 (22.9) Satisfied 31 31 Heart rate before procedure (bpm) 80.4 (11.1) 78.6 (13.2) Normal 8 5 Use of a painkiller (%) 82 88 Dissatisfied 2 2 Difficulty of procedure (%) Very dissatisfied 0 0 Very easy 27 37 Doctor refuses same 5 2 0.610 procedure in same Easy 40 23 setting for this patient (%) Normal 19 34 Satisfaction doctor (%) 0.165 Difficult 11 3 Very satisfied 50 60 Very difficult 3 3 Satisfied 29 20 Intervention (%) Normal 13 5 Diagnostic 23 31 Dissatisfied 0 10 Biopsies 23 21 Very dissatisfied 8 5 Therapeutic 54 48 Complications (%) 0 0 NS Diameter 5.5 mm Hysteroscope (%) 67 74 STAI 1 score after procedure 34.1 (8.6) 35.9 (9.6) 0.491 STAI 1 score before procedure 40.7 (13.0) 42.6 (12.5) STAI 1 score difference 6.3 (12.8) 5.7 (10.9) 0.820 STAI 2 score 34.0 (8.0) 36.0 (10.5) Data are expressed as mean (SD) or percentage Data are expressed as mean (SD) or percentage NS not significant Mak et al. Gynecological Surgery (2017) 14:14 Page 5 of 8 Colposcopy patient and doctor (p > .05) (Table 4). No complica- Eighty participants were included, 42 participants in the tions occurred. music group and 38 participants in the control group. In In five cases in the music group (12%), the doctor no- each group, 3 participants did not meet the inclusion ticed he or she was disturbed by the music during the criteria because no biopsy or LLETZ was performed dur- procedure. In three of these cases, the volume of the ing colposcopy. These participants were excluded from music was too loud; in one case, the music was not of further analyses. Therefore, 74 participants (39 music the genre preferred by the doctor; and in the last case, group and 35 control group) were considered for statis- no explanation was given. In one case in the music tical analyses. One participant of the music group re- group, the doctor was dissatisfied without mentioning a fused music during the procedure (Fig. 2). reason (3%). The most popular music genre chosen in Baseline characteristics are shown in Table 3. A signifi- the music group was pop music (67%), followed by cant difference between the groups was found for dys- classical music (18%) and spa music (15%). menorrhoea (24.1 (24.8) mm vs. 38.2 (22.9) mm, In addition to the intention-to-treat analysis, a per- p = .013) and the performance of a cervical block (72 vs. protocol analysis was performed only for the primary 47%, p = .031). For all other characteristics, no difference outcome because one participant refused music. Still no was found (p > .05). No significant difference was found difference was found in pain between the groups (33.3 for pain during the procedure between the music group (24.0) mm vs. 30.7 (27.4) mm, p = .579). Dysmenorrhoea and control group (32.4 (24.3) mm vs. 31.6 (27.3) mm, and performance of a cervical block were both different p = .826). Secondary outcomes were also similar, in- between the groups (Table 3). After performing a linear cluding heart rate and anxiety during the procedure, regression, we concluded that both variables are con- pain after the procedure and satisfaction of the founders for the primary outcome. Correction of these Fig. 2 Colposcopy: flow chart patient inclusion Mak et al. Gynecological Surgery (2017) 14:14 Page 6 of 8 Table 3 Colposcopy: patient characteristics Table 4 Colposcopy: results Music group Control group Music group Control group P value N =39 N =35 N =39 N =35 Age (y) 38.8 (8.3) 38.9 (10.7) Pain during procedure 32.4 (24.3) 31.6 (27.3) 0.826 (mm VAS) Height (m) 1.69 (0.06) 1.70 (0.06) Pain after procedure 23.6 (21.5) 27.6 (25.6) 0.637 Weight (kg) 69.0 (13.3) 69.6 (17.8) (mm VAS) Body mass index 24.0 (4.1) 24.1 (6.1) Heart rate during 82.4 (16.1) 82.7 (15.1) 0.929 procedure (bpm) Dysmenorrhea (mm VAS) 24.1 (24.8) 38.2 (22.9) Patient recommends 95 88 0.408 Expected pain (mm VAS) 43.1 (23.9) 49.4 (22.1) a friend (%) Heart rate before procedure 78.2 (15.1) 82.1 (14.8) Patient satisfaction (%) 0.571 (bpm) Very satisfied 77 79 Use of a painkiller (%) 8 9 Satisfied 15 15 Use of cervical block (%) 72 47 Normal 3 3 Pap smear score (PAP) (%) Dissatisfied 5 0 PAP 2 29 26 Very dissatisfied 0 3 PAP 3a 48 48 Doctor refuses same 5 3 1.000 PAP 3b 23 26 procedure in same Colposcopic impression (%) setting for this patient (%) Normal 6 7 Satisfaction doctor (%) 0.769 Low grade 47 64 Very satisfied 74 79 High grade 44 29 Satisfied 18 15 Carcinoma 3 0 Normal 5 6 Difficulity of procedure (%) Dissatisfied 3 0 Very easy 47 65 Very dissatisfied 0 0 Easy 29 26 Complications (%) 0 0 NS Normal 18 0 STAI 1 score after 38.4 (15.3) 35.5 (9.6) 0.584 procedure Difficult 3 6 STAI 1 score difference 3.8 (14.4) 7.5 (10.2) 0.463 Very difficult 3 3 Data are expressed as mean (SD) or percentage Intervention (%) NS not significant Cold biopsy 28 54 Hot biopsy 3 0 was evaluated as well. We found no positive effect of music, neither in hysteroscopy nor in colposcopy. LLETZ 69 46 STAI 1 score before 42.1 (12.3) 42.6 (8.7) Strength and limitations procedure To our knowledge, this is the first randomized controlled STAI 2 score 34.9 (10.1) 34.3 (7.9) trial investigating the effect of music in gynaecological of- Data are expressed as mean (SD) or percentage fice procedures taking into account the opinion of the doc- tor. Moreover, we explored the additional effect of music in variables for pain during the procedure resulted in the daily practice. Methods that were already used to improve same conclusion, i.e. no statistical significance between patients’ experience remained unchanged with respect to the two groups (p = .806). A per-protocol analysis with the standard procedure to increase external validity. An- correction for these two confounders showed the same other asset of this study is its use of single-blind testing. result (p = .563). The participants in this study were not informed about the role of musicinthisstudy;theywereonlyinformedabout Discussion the goal to improve patients’ experience during office pro- Main findings cedures in a non-invasive manner with a controlled trial. The aim of this study was to measure the additional effect This is unique in comparison to other studies. of music in gynaecological office procedures on patients’ A limitation of this study is that waiting time and dur- level of pain, anxiety and satisfaction during and after the ation of the procedure were not examined. Waiting time procedure in daily practice. The experience of the doctor can possibly change the anxiety and pain level of the patient Mak et al. Gynecological Surgery (2017) 14:14 Page 7 of 8 and prolonged duration of the procedure can increase the of Danhauer et al., iPods with speakers were used in dissatisfaction of the patient and the doctor. Another limi- our study, giving the same result. tation is the difference in experience between the doctors. The potential positive effect of music may have been In both groups, hysteroscopy and colposcopy, the doctors overpowered by the multimodal approach in our study. consisted of both gynaecologists and residents. According The use of information leaflets, analgesics, the inter- to the literature, pain scores can be lower when an experi- action between patient and doctor, a nurse to offer enced doctor performs the procedure [17]. iPod speakers emotional support and the use of videoscopy are all were used to play the music which prevented double-blind used in daily practice. For that reason, they remained testing. However, during the pilot study, headphones turned unchanged with respect to the standard procedure in out to impede the interaction between patient and doctor. this trial. Information leaflets increase the patient’s For this reason, headphones were waived. knowledge and therefore could improve the patient’sex- perience [7]. The value of oral analgesics is limited [3, 18], Interpretation but local anaesthesia could be effective at achieving pain Despite randomization, we found a difference between relief [3]. A monitor for videocolposcopy, allowing the pa- dysmenorrhoea and the use of a cervical block between tient to view the procedure, reduces patient anxiety and the groups in the patients receiving a colposcopy. The pain during routine colposcopic examination [16]. Finally, women in the music group had less dysmenorrhoea, but active emotional support can reduce pain [19]. more of them received cervical anaesthesia (Table 3). Another explanation for our results, which is possibly Significantly, less dysmenorrhoea could imply a higher associated with the multimodal approach described pain threshold in that group which may confound the above, is the relatively low pain score in our trial. The primary outcome. The difference in cervical anaesthesia control group in the colposcopy group showed lower could be explained by the difference in intervention be- scores in comparison with the trials of Chan et al. and tween the groups (p = .056). Women who underwent Danhauer et al., namely 31.6 in this trial versus 50.3 and cold biopsies did not receive a cervical block in contrast 51.7 in the other trials. The power analysis and expected with electrical biopsies and LLETZ. The cervical block pain reduction in this trial were based on these results given in this trial consists of an anaesthetic (articaine) and from previous trials. Moreover, a score of VAS 40 is fre- a vasoconstrictor (epinephrine). According to Gajjar et al., quently used in the literature as a pain threshold [17, 20, receiving local anaesthetics and a vasoconstrictor could 21]. Therefore, with an initial pain score lower than 40, possibly reduce pain experience in women undergoing the clinical relevance of pain relief is doubtful. Thus, we colposcopy. Therefore, the difference in dysmenorrhoea believe that our multimodal approach already greatly im- and the use of a cervical block between the groups is rele- proves patients’ experience and possibly hereby camou- vant. For this reason, a correction was performed for these flages the potential effect of music. confounders. Still, no difference was found between the We found no difference in the satisfaction of the doc- music group and control group. Thus, the result remained tors between the music group and the control group for unchanged. both hysteroscopy and colposcopy. However, some doc- Previous research in music for pain relief showed a large tors mentioned that they were disturbed by the music; difference in results with high heterogeneity in studies as one case in the hysteroscopy group (3%) and five cases described in the systematic review of Cepeda et al. A posi- in the colposcopy group (12%). The difference between tive effect of music in gynaecological office procedures the two groups can be explained by the different doctors was found in randomized controlled trials performed by performing a hysteroscopy or a colposcopy. Despite the Angioli et al. and Chan et al. However, another random- fact that the volume could be adjusted, the reasons they ized controlled trial by Danhauer et al. found no difference mentioned for their irritation were the volume of the between the music group and the control group for pain, music and the fact that it was not the kind of music they anxiety or satisfaction. These results are similar to the enjoy. Therefore, perhaps the use of more neutral music results in this current trial. Danhauer et al. suggest that set at a lower volume would satisfy these doctors. Unfor- their results are probably different from the results of tunately, we did not examine the music preferences of the two previously mentioned trials because of the lim- the doctors. ited choice of five music genres, the number of physi- cians and the difficulty in hearing what the doctor was Conclusion saying because of the headphones. However, according In conclusion, our study showed no positive effect of music to a systematic review, the decline in pain intensity is regarding pain, anxiety or satisfaction for office hysteros- similar in studies wherein patients selected the type of copy and colposcopy. We believe a multimodal approach music and in those wherein patients did not select their should be used to decrease patient distress in terms of pain music[9].Instead of theheadphonesusedinthe trial and anxiety, with or without music. Mak et al. Gynecological Surgery (2017) 14:14 Page 8 of 8 Funding 12. Chan YM, Lee PW, NG TY, et al (2003) The use of music to reduce anxiety This study did not receive any funding. for patients undergoing colposcopy: a randomised trial. Gynecol Oncol 91(1):213–217 Authors’ contributions 13. Angioli R, De Cicco Nardone C, Plotti F, et al. (2014) Use of music to reduce NM contributed to the protocol development, data collection, data anxiety during office hysteroscopy: prospective randomized trial. J Minim analysis and manuscript writing. IMAR contributed to the data collection Invasive Gynecol 21(3):454–459. doi:10.1016/j.jmig.2013.07.020 and manuscript writing. SAS contributed to the protocol development and 14. Pluyter JR, Buzink SN, Rutkowski AF, Jakimowics JJ (2010) Do absorption and data collection. EHMNW contributed to the protocol development, data realistic distraction influence performance of component task surgical collection and manuscript writing. JWMM contributed to the manuscript procedure? Surg Endosc 24(4):902–907. doi:10.1007/s00464-009-0689-7 writing. MYB contributed to the protocol development and manuscript 15. Way TJ, Long A, Weihing J, et al (2013) Effect of noise on auditory writing. All authors read and approved the final manuscript. processing in the operating room. J Am Coll Surg 216(5):933–938. doi:10.1016/j.jamcollsurg.2012.12.048 Ethics approval and consent to participate 16. Walsh JC, Curtis R, Mylotte M (2004) Anxiety levels in women attending a The trial was approved by the Medical Ethics Committee of the hospital colposcopy clinic: a randomised trial of an educational intervention using (Study number 2014–28). The committee determined that this study did not video colposcopy. Patient Educ Couns 55(2):247–251 belong to the scope of the medical research involving human subjects act. 17. Campo R, Molinas CR, Rombouts L et al (2005) Prospective multicentre randomized controlled trial to evaluate factors influencing the success rate Consent for publication of office diagnostic hysteroscopy. Hum Reprod 20(1):258–263 Informed consent was obtained from all individual participants included in 18. Tam WH, Yuen PM (2001) Use of diclofenac as an analgesic in outpatient the study. hysteroscopy: a randomized, double-blind, placebo-controlled study. Fertil Steril 76(5):1070–1072 Competing interests 19. Ireland LD, Allen RH (2016) Pain management for gynecologic procedures The authors declare that they have no competing interests. in the office. Obstet Gynecol Surv 71(2):89–98. doi:10.1097/OGX. 20. Cepeda MS, Africano JM, Polo R et al (2003) What decline in pain intensity Publisher’sNote is meaningful to patients with acute pain? Pain 105(1–2):151–157 Springer Nature remains neutral with regard to jurisdictional claims in 21. Litta P, Cosmi E, Saccardi C et al (2008) Outpatient operative polypectomy published maps and institutional affiliations. using a 5 mm-hysteroscope without anaesthesia and/or analgesia: advantages and limits. Eur J Obstet Gynecol Reprod Biol 139(2):210–214. doi: Author details 10.1016/j.ejogrb.2007.11.008 Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands. Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo, The Netherlands. Department of Obstetrics and Gynaecology, Rode Kruis Hospital, Beverwijk, The Netherlands. Department of Obstetrics and Gynaecology, GROW—School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands. Received: 22 March 2017 Accepted: 26 July 2017 References 1. Bettocchi S, Nappi L, Ceci O, Selvaggi L (2004) Office hysteroscopy. Obstet Gynecol Clin N Am 31:641–654 2. Nagele F, OÇonnor H, Davies A, et al (1996) 2500 Outpatient diagnostic hysteroscopies. Obstet Gynecol 88(1):87–92 3. Gajjar K, Martin-Hirsch PPL, Bryant A, Owens GL (2016) Pain relief for women with cervical intraepithelial neoplasia undergoing colposcopy treatment. Cochrane Database Syst Rev 18;7:CD006120.doi:10.1002/14651858.CD006120 4. Marteau TM, Walker P, Giles J et al (1990) Anxieties in women undergoing colposcopy. BJOG 97:859–861 5. Gambadauro P, Navaratnarajah R, Carli V (2015) Anxiety at outpatient hysteroscopy. Gynec Surg 12(3):189–196 6. Ahmad G, O’Flynn H, Attarbashi S, et al (2010) Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev 10;(11):CD007710. doi: 10.1002/ 14651858.CD007710 7. Galaal K, Bryant A, Deane KHO et al (2011) Interventions for reducing anxiety in women undergoing colposcopy. Cochrane Database Syst Rev 7(12):CD006013. doi:10.1002/14651858.CD006013 8. De Carvalho Schettini JA, Ramos de Amorim MM, Ribeiro Costa AA, Albuquerque Neto LC et al (2007) Pain evaluation in outpatients undergoing diagnostic anesthesia-free hysteroscopy in a teaching hospital: a cohort study. J Minim Invasive Gynecol 14(6):729–735 9. Cepeda MS, Carr DB, Lau J, Alvarez H (2006) Music for pain relief. Cochrane Database Syst Rev 19;(2):CD004843 10. Wang MW, Zhang LY, Zhang YL, et al (2014) Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med 15(10):1786–1794. doi:10.1111/pme.12514 11. Danhauer SC, Marler B, Rutherford CA et al (2007) Music or guided imagery for women undergoing colposcopy: a randomized controlled study of effects on anxiety, perceived pain, and patient satisfaction. J Low Genit Tract Dis 11(1):39–45

Journal

Gynecological Surgery – Springer Journals

Published: Aug 9, 2017

There are no references for this article.