The Use of Music in Reducing Pain During Outpatient Hysteroscopy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hysteroscopy

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music group<br>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<br>* 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.<br>|
| No Intervention: Non-music group<br>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?
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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 |