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OpenTrials
Completed

NCT Number: NCT04426110

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department Saint Antoine Hospital (AP-HP)

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Maximal pain level

    Time frame: Day 0

    Maximum pain level experienced during the procedure, measured by visual analog scale immediately after the procedure.

Secondary outcomes

  1. Maximal anxiety level

    Time frame: Day 0

    Maximum anxiety level experienced during the procedure, measured by visual analog scale immediately after the procedure.

  2. Final pain level

    Time frame: Day 0

    Final pain level measured by visual analog scale immediately after the procedure.

  3. Final anxiety level

    Time frame: Day 0

    Final anxiety level measured by visual analog scale immediately after the procedure.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PLAY

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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