Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches

Completed

• Conditions: Wound

• Registration Number: NCT04426110
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.

Detailed Description

Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits), inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being the most frequently used procedure.

Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with painful bedside procedures. Music is one of them, easy to use and without any side effects.

Music therapy has already been shown to reduce pain and anxiety levels in children during medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical or anaesthetic procedures.

Our objective is to apply this technic to adults in emergency departments during stitches wound management.

This is a study before / after the implementation of a music therapy protocol during stiches wound management. During the music period, the participant will choose and listen to one of the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a professional music therapist, via headphones. There will be no change in stitches wound management.

Pain and anxiety levels will be measured by visual analog scale before, during and after the stitches procedure.

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-06-30
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• ≥ 18 years old
• Acute skin wound with need for stitches
• National health service coverage
• No opposition

Exclusion Criteria

• Conditions interfering with consent or measures (no French-fluent, acute intoxication, neurologic or psychiatric pathology)
• Wound requiring surgical exploration
• Wound localized on or around an ear
• Major insufficiency of auditory function

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal pain level	Day 0	Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.

Secondary Outcome Measures

Name	Time	Method
Maximal anxiety level	Day 0	Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.
Final pain level	Day 0	Final pain level measured by visual analog scale immediately after the procedure.
Final anxiety level	Day 0	Final anxiety level measured by visual analog scale immediately after the procedure.

Trial Locations

Locations (1)

Emergency Department Saint Antoine Hospital (AP-HP); 🇫🇷 Paris, France