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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Emergency Department Saint Antoine Hospital (AP-HP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients visiting the emergency department for an acute skin wound with need for stitches.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Period 1 "Control"; No Music. Wound stitches procedure conducted according to clinical practice.
Period 2 "Music"; Music by headphones. Wound stitches procedure conducted according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal pain level	Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal anxiety level	Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.	Day 0
Final pain level	Final pain level measured by visual analog scale immediately after the procedure.	Day 0
Final anxiety level	Final anxiety level measured by visual analog scale immediately after the procedure.	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pierre-Clément THIEBAUD, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
• Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
• Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Wound; Music; Stitches
• Other Study ID Numbers: APHP200330

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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