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NCT04232930 Clinical Trial

The Use of Music in Reducing Pain During Outpatient Hysteroscopy

Hysteroscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04232930
Other study ID # HKECREC-2019-034
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date December 31, 2019

Study information
Verified date May 2020
Source Pamela Youde Nethersole Eastern Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Hong Kong Pamela Youde Nethersole Eastern Hospital Hong Kong HongKong

Sponsors (1)
Lead Sponsor Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

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. 2020 Feb;29(1):10-19. doi: 10.1080/13645706.2019.1576054. Epub 2019 Feb 22. — View Citation

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. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Systolic blood pressure Systolic blood pressure Systolic blood pressure before hysteroscopy
Secondary Systolic blood pressure Systolic blood pressure Systolic blood pressure during hysteroscopy
Secondary Diastolic blood pressure Diastolic blood pressure Diastolic blood pressure before hysteroscopy
Secondary Diastolic blood pressure Diastolic blood pressure Diastolic blood pressure during hysteroscopy
Secondary Heart rate Heart rate Heart rate before hysteroscopy
Secondary Heart rate Heart rate Heart rate during hysteroscopy
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