The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial
Phase: NA
Conditions: Hysteroscopy
Sponsor: Pamela Youde Nethersole Eastern Hospital

 
 
 
The use of music in reducing pain during 
outpatient hysteroscopy: prospective 
randomised trial 
NCT04232930 
14 May 2019 
 
 

 
 
The use of music in reducing pain during outpatient hysteroscopy: prospective randomised trial 
Dr. Law Ho Ying (MBBS), Department of Obstetrics and Gynaecology, Pamela Youde Nethersole Eastern 
Hospital   
Dr. Ng Yuet Tao Dorothy, Department of Obstetrics and Gynaecology, Pamela Youde Nethersole Eastern 
Hospital 
Dr. Carmen Diana Chung, Department of Obstetrics and Gynaecology, Pamela Youde Nethersole Eastern 
Hospital 
 
Background and literature search 
Outpatient hysteroscopy is nowadays a commonly used procedure in Gynaecology in order to evaluate 
the uterine cavity and to diagnose different intrauterine diseases. It is a safe, convenient and cost-
effective procedure in aiding the management of abnormal uterine bleeding [1]. However, outpatient 
hysteroscopy can be associated with significant pain [2] which would have impact on the woman’s 
satisfaction and pain is one of the most common reasons for failure of the procedure [3]. 
 
Listening to music could be an easy and non-invasive way to reduce pain. A meta-analysis conducted on 
the effects of music on pain revealed that music interventions had statistically significant effects in 
decreasing pain on 0-10 pain scales [4]. Researches on this topic in gynaecological office procedures, 
however, showed variation in the results. The randomized controlled trial of Mak et al. showed no 
positive effect of music on patient’s level of pain, anxiety or satisfaction of patient or doctor for office 
hysteroscopy and colposcopy [5]. On the other hand, Angioli et al. showed a positive effect of the use of 
music with a reduction of pain and anxiety during office hysteroscopy [6]. A local randomized controlled 
trial of Chan et al. also showed that music can significantly reduce pain during colposcopy examination 
[7]. 
 
Thus, the aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients’ 
level of pain and satisfaction.  This may have a role in our daily practice in providing a better patient care 
in outpatient hysteroscopy. 
Hypothesis/research question 
Is music an effective measure to reduce pain during outpatient hysteroscopy? 
 
Objectives of the study 
This study aims to investigate the effect of music in reducing pain during outpatient hysteroscopy.  
 
Methods 

 
 
Design 
This will be a prospective randomized trial to be conducted in the Department of Obstetrics and 
Gynaecology, Pamela Youde Nethersole Eastern Hospital from June 2019 to December 2019. 
 
Participants 
All patient referred for outpatient hysteroscopy from June 2019 to December 2019 will be invited to join 
the study. Inclusion criteria were indication for hysteroscopy (abnormal uterine bleeding, abnormal 
findings on ultrasound, and infertility), signed informed consent, and ability to read Chinese or English. 
Exclusion criteria were hearing impairment, known anatomical abnormalities which would make 
performing the procedure more difficult and use of premedication for cervical ripening. Withdrawal 
criteria was procedure cannot be completed.  
 
Outcomes 
The primary outcome is the experience of pain during hysteroscopy, measured with the visual analog 
scale (VAS) on a 0-10 scale, with 0 indicating “no pain” and 10 indicating “worst pain possible”.  Each 
participant will assess the anticipated pain before the procedure and also the real pain after the 
procedure using VAS. Secondary outcomes are vitals parameters including blood pressure and heart 
rate. They will be recorded before the procedure and during the hysteroscopy after traversing the 
cervix. Satisfaction of the patient and doctor will be described using a scale of 1 to 5 after the procedure. 
 
Procedure 
Written informed consent will be obtained from each participant before data collection and the 
procedure. Background characteristics including age, body mass index, occupation, religion, education, 
marital status, parity, number of vaginal deliveries and history of hysteroscopic surgery will be collected. 
Participants will be randomized to the music group or control group. Sealed numbered opaque envelops 
will be used for randomization. Participants in the music group will be asked to choose among pop, 
classical, jazz or spa music playlists which are prepared by the study team. The music that chosen by the 
participant will be played through a speaker by the nursing staff. Music will be played through a speaker 
instead of headphone in order to maintain a good communication and interaction between the 
participant and the doctor. The volume of the music can also be adjusted according to individual 
preference. On the other hand, participants in the control group will be examined in the same setting 
without music.  
Hysteroscopy will be performed in a dedicated room in the day ward by resident trainees without any 
type of anaesthesia. No premedication will be given. The procedures of hysteroscopy will be 
standardized. Participant will be put in lithotomy position. A Bivalve speculum or Sims speculum will be 
used to visualized the cervix. Tenaculum might be used depending on surgeon’s preference. Normal 
saline was used as the distending medium. A CAMPO TROPHYSCOPE of outer diameter 2.9mm will be 
used. An operating sheath of outer diameter 4.4mm might be applied to the hysteroscope if necessary. 

 
 
The operative time will be measured from entry of the hysteroscope into external os to exit from the 
cervix. The type of procedure (diagnostic or operative) performed will be measured again after insertion 
of the hysteroscope through internal os. 
 
Sample size and statistical methods 
The mean decrease in VAS ranged from 4.83 to 2.95, as reported in the literature [6]. Fifty-one 
participants in each group will be required to detect such a difference, with a power of 90%. Statistical 
analysis would be performed with Statistical Package for the Social Sciences (SPSS). Student’s t test and 
Chi square test would be used where appropriate. Patients’ demographic data would be presented in 
tables or graphs. Paired t test would also be performed, if appropriate. P value of <0.05 would be 
considered as statistically significant. 
 
Ethical consideration 
The issue of confidentiality is the major ethical issue, and will be solved by recording the data in a 
manner that does not allow the participants to be identified (ie. using a non-recognizable code for each 
patient). 
The protocol complies with the ICH-GCP. 
 
Data Handling and Record Keeping 
Records identifying the subject will be kept confidential and, to the extent permitted by the applicable 
laws and/or regulations, will not be made publicly available. If the results of the trial are published, the 
subject’s identity will remain confidential. 
To protect patient privacy, all research data would be handled in line with HA/Hospital’s policy in 
handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the 
department or ward keeps patients’ confidential information. Electronic data should be saved in secured 
computer of the hospital with restricted access. 
Day ward staff and the principal investigator will be responsible for safekeeping of the personal data 
during and after the study. Only the principal investigator and delegate will have access to the personal 
data collected during and after the study. The personal data will be kept for 3 years after the study. All 
the personal data will be discarded and destroyed after the storage period. 
 
Reference 
[1] Best Practice in Outpatient Hysteroscopy. RCOG Green-Top Guideline No.59. March 2011. 
[2] Morgan M, Dodds W, Wolfe C, Raju S. Women's views and experiences of outpatient hysteroscopy: 
implications for a patient-centered service. Nurs Health Sci. 2004 Dec. 

 
 
[3] Amer-Cuenca JJ, Marín-Buck A, Vitale SG, La Rosa VL, Caruso S, Cianci A, Lisón JF. Non-
pharmacological pain control in outpatient hysteroscopies. Minim Invasive Ther Allied Technol. 2019 Feb 
22.  
[4] Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. Epub 
2016 Oct 19.  
[5] Mak N, Reinders IMA, Slockers SA, Westen EHMN, Maas JWM, Bongers MY. The effect of music in 
gynaecological office procedures on pain, anxiety and satisfaction: a randomized controlled trial. 
Gynecol Surg. 2017;14(1):14. 
[6] Angioli R, De Cicco Nardone C, Plotti F, Cafà EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova 
C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim 
Invasive Gynecol. 2014 May-Jun;21(3):454-9. 
[7] Chan YM1, Lee PW, Ng TY, Ngan HY, Wong LC. The use of music to reduce anxiety for patients 
undergoing colposcopy: a randomized trial. Gynecol Oncol. 2003 Oct;91(1):213-7. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Research title: The use of music in reducing pain during outpatient hysteroscopy: prospective 
randomised trial" 
 
I hereby consent to participate in the research study. 
 
I have read and understand this document. The study has been explained to me. I understand all the 
benefits and risks related to this study. I have opportunities to raise questions to the investigators and 
they have answered my questions to my satisfaction. I have collected sufficient information regarding this 
study. 
 
If I have any physical or emotional discomfort as a result of participating in this study, the study 
investigators will treat me, or will refer me to receive treatment. Signing this informed consent form does 
not imply that my legal rights would be waived.  
 
I understand that I can freely withdraw my consent on the participation of this study and it would not 
affect my present and future medical care.  
 
I understand my identity will be kept confidential. I also authorize the research ethics committee and the 
regulatory authority(ies) to access my data for verification of clinical trial procedures and/or data, without 
violating the my confidentiality, to the extent permitted by the applicable laws and regulations. 
 
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and information sheet for storage.