Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches
PLAY
1 other identifier
observational
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2020
CompletedOctober 18, 2021
October 1, 2021
5 months
June 8, 2020
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal pain level
Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.
Day 0
Secondary Outcomes (3)
Maximal anxiety level
Day 0
Final pain level
Day 0
Final anxiety level
Day 0
Study Arms (2)
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
Eligibility Criteria
All adult patients visiting the emergency department for an acute skin wound with need for stitches.
You may qualify if:
- ≥ 18 years old
- Acute skin wound with need for stitches
- National health service coverage
- No opposition
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emergency Department Saint Antoine Hospital (AP-HP)
Paris, 75012, France
Related Publications (3)
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.
PMID: 16625614BACKGROUNDKlassen 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.
PMID: 18355741BACKGROUNDKuhlmann 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.
PMID: 29665028BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-Clément THIEBAUD, MD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 11, 2020
Study Start
June 30, 2020
Primary Completion
December 10, 2020
Study Completion
December 10, 2020
Last Updated
October 18, 2021
Record last verified: 2021-10