- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04426110
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Paris, Frankrig, 75012
- Emergency Department Saint Antoine Hospital (AP-HP)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maximal pain level
Tidsramme: Day 0
|
Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.
|
Day 0
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maximal anxiety level
Tidsramme: Day 0
|
Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.
|
Day 0
|
Final pain level
Tidsramme: Day 0
|
Final pain level measured by visual analog scale immediately after the procedure.
|
Day 0
|
Final anxiety level
Tidsramme: Day 0
|
Final anxiety level measured by visual analog scale immediately after the procedure.
|
Day 0
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Pierre-Clément THIEBAUD, MD, Assistance Publique - Hôpitaux de Paris
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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