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

Wound Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426110
• Other study ID #: APHP200330
• Status: Completed
• Start date: June 30, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Wound

Locations

Country	Name	City	State
France	Emergency Department Saint Antoine Hospital (AP-HP)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004843. — View Citation

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. Review. — View Citation

Kühlmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal pain level	Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.	Day 0
Secondary	Maximal anxiety level	Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.	Day 0
Secondary	Final pain level	Final pain level measured by visual analog scale immediately after the procedure.	Day 0
Secondary	Final anxiety level	Final anxiety level measured by visual analog scale immediately after the procedure.	Day 0