Clinical trial NCT04232930: The Use of Music in Reducing Pain During Outpatient Hysteroscopy
Official title: The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 107
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensity of pain
timeFrame: Anticipated pain before hysteroscopy
measure: Intensity of pain
timeFrame: Actual pain experienced during hysteroscopy
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Systolic blood pressure before hysteroscopy
measure: Systolic blood pressure
timeFrame: Systolic blood pressure during hysteroscopy
measure: Diastolic blood pressure
timeFrame: Diastolic blood pressure before hysteroscopy
measure: Diastolic blood pressure
timeFrame: Diastolic blood pressure during hysteroscopy
measure: Heart rate
timeFrame: Heart rate before hysteroscopy
measure: Heart rate
timeFrame: Heart rate during hysteroscopy
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
state: HongKong
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Ho Ying Law
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1442-2018.2004.00202.x.
citation: 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.
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.
citation: 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.
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. doi: 10.1016/s0090-8258(03)00412-8.
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.