The Use of Music in Reducing Pain During Outpatient Hysteroscopy

The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Hysteroscopy
• Intervention / Treatment: Other: Music

Detailed Description

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. However, outpatient hysteroscopy can be associated with significant pain which would have impact on the woman's satisfaction and pain is one of the most common reasons for failure of the procedure.

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. Researches on this topic in gynaecological office procedures, however, showed variation in the results. Some showed no positive effect of music on patient's level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. On the other hand, some studies showed a positive effect of the use of music with a reduction of pain and anxiety during office hysteroscopy.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • HongKong
    • Hong Kong, HongKong, Hong Kong, 00000
      • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
• signed informed consent
• ability to read Chinese or English.

Exclusion Criteria:

• hearing impairment
• known anatomical abnormalities which would make performing the procedure more difficult
• use of premedication for cervical ripening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Music group; In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. 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.	Other: Music; Four types of music will be provided, including pop, classical, jazz or spa music which are prepared by the study team. They contain instrumental songs only without vocal.
NO_INTERVENTION: Non-music group; Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Pain measured using visual analog scale (VAS) on a 0-10 scale, with 0 indicating "no pain" and 10 indicating "worst pain possible".	Anticipated pain before hysteroscopy
Intensity of pain	Pain measured using visual analog scale (VAS) on a 0-10 scale, with 0 indicating "no pain" and 10 indicating "worst pain possible".	Actual pain experienced during hysteroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure	Systolic blood pressure before hysteroscopy
Systolic blood pressure	Systolic blood pressure	Systolic blood pressure during hysteroscopy
Diastolic blood pressure	Diastolic blood pressure	Diastolic blood pressure before hysteroscopy
Diastolic blood pressure	Diastolic blood pressure	Diastolic blood pressure during hysteroscopy
Heart rate	Heart rate	Heart rate before hysteroscopy
Heart rate	Heart rate	Heart rate during hysteroscopy

Collaborators and Investigators

• Sponsor: Pamela Youde Nethersole Eastern Hospital
• Investigators: Principal Investigator: Ho Ying Law, Pamela Youde Nethersole Eastern Hospital

Publications and helpful links

General Publications

• 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;6(4):315-20. doi: 10.1111/j.1442-2018.2004.00202.x.
• Amer-Cuenca JJ, Marin-Buck A, Vitale SG, La Rosa VL, Caruso S, Cianci A, Lison JF. Non-pharmacological pain control in outpatient hysteroscopies. Minim Invasive Ther Allied Technol. 2020 Feb;29(1):10-19. doi: 10.1080/13645706.2019.1576054. Epub 2019 Feb 22.
• 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. doi: 10.1186/s10397-017-1016-2. Epub 2017 Aug 9.
• Angioli R, De Cicco Nardone C, Plotti F, Cafa 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. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.
• Chan YM, 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. doi: 10.1016/s0090-8258(03)00412-8.
• Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. Erratum In: J Music Ther. 2021 Aug 24;58(3):372.

Helpful Links

• Best Practice in Outpatient Hysteroscopy

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HKECREC-2019-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The following individual participant data will be shared:

• Background characteristics including age, body mass index, occupation, religion, education, marital status, parity and number of vaginal deliveries and history of hysteroscopic surgery
• Details of the outpatient hysteroscopy including time, procedure and level of performing surgeon

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: When a third party is interested to reanalyze study data or to combine data from multiple studies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No