Clinical trial NCT04426110: Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches
Official title: Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches in Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Keywords: Wound
Stitches
Pain
Anxiety
Music
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients visiting the emergency department for an acute skin wound with need for stitches.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal pain level
timeFrame: Day 0
Secondary outcomes:
measure: Maximal anxiety level
timeFrame: Day 0
measure: Final pain level
timeFrame: Day 0
measure: Final anxiety level
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Emergency Department Saint Antoine Hospital (AP-HP)
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre-Clément THIEBAUD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.