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Evaluation of Musicotherapy on Pain During Wound Closure in the Emergency Department (EMERGENCE)

Primary Purpose

Wounds Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Musicotherapy
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wounds Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years admitted to ER with suturable wound (at least 1 stitch)
  • able to understand and express oneself
  • giving free, informed and written consent signed by the participant and the investigator

Exclusion Criteria:

  • who has a severe wound with suspected open fracture or requiring surgical exploration in the operating room
  • with severe hearing loss or deafness, speech disorders or any acute or chronic condition that compromises listening (at the investigator's discretion), musicogene epilepsy
  • no social security cover
  • unable to decide for himself or herself (at the discretion of the investigator): confused patient, foreign language not understood by the investigator, severe acute intoxication, patient with severe neurological or psychiatric comorbidity
  • under judicial protection

Sites / Locations

  • CHU de la RéunionRecruiting
  • CHU de la RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Musicotherapy

Standard care

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
Comparison of maximal pain using visual analogic scale score between the two groups (scale ranking from 0 to 10, with 0 meaning better score (no pain/no anxiety) and 10 the worse score (maximal pain/anxiety).

Secondary Outcome Measures

Full Information

First Posted
May 19, 2022
Last Updated
July 20, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT05388591
Brief Title
Evaluation of Musicotherapy on Pain During Wound Closure in the Emergency Department
Acronym
EMERGENCE
Official Title
Evaluation of Musicotherapy (Application Music Care) on Pain During Wound Closure in the Emergency Department : a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness of music listening (with a musicotherapy application Music Care) on patients pain associated with care during wound suturing in the Adults emergency unit.
Detailed Description
BACKGROUND - Music therapy is known as an effective adjuvant treatment for the management of physical pain and anxiety. It is recognised in various medical fields. Wound suturing in the Emergency Department is a potentially stressful and painful experience for patients. OBJECTIVE - To evaluate the effectiveness of music listening (with a musicotherapy application Music Care) on patients pain associated with care during wound suturing in the Adults emergency department. METHODS - Therefore, a prospective, randomised, open-label, multi-centre interventional will be conducted in two Adults Emergency departments of the Reunion Island University hospitals. Patients over 18 years old admitted to the Adults Emergency Departments with a suturable wound (at least one stitch), able to understand and express themselves will be included. The primary outcome is the comparison of maximal VAS score between the two groups. Secondary outcomes are the absolute change in heart rate, systolic and diastolic blood pressure, respiratory rate, absolute change in anxiety score, suture duration related to the number of stitch, overall patient and practitioner satisfaction. The baseline data collection includes patient age and sex, pain and stress VAS and biological parameters (heart rate, blood pressure, respiratory rate) at admission in box and immediately after suturing. In order to demonstrate a difference of 10mm on VAS with a standard deviation of 20mm, a power of 90% and an alpha risk of 0,05, the number of subjects required is 192. A multivariate analysis was performed on the association between exposure : music/no music and the judgement criteria. Subgroup analyses are planned for age, gender, additional analgesia used, location, duration of analgesia used, location, duration of suture and number of stitches. EXPECTED RESULTS - Thanks to music therapy, a decrease of pain and anxiety associated with sutures in the Emergency room is expected, but also an improvement in the working conditions hospital physicians in the emergency room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds Injuries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Musicotherapy
Arm Type
Experimental
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Musicotherapy
Intervention Description
Music listening with the application Music Care (style of music chosen by the patient) during wound suturing
Primary Outcome Measure Information:
Title
Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
Description
Comparison of maximal pain using visual analogic scale score between the two groups (scale ranking from 0 to 10, with 0 meaning better score (no pain/no anxiety) and 10 the worse score (maximal pain/anxiety).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years admitted to ER with suturable wound (at least 1 stitch) able to understand and express oneself giving free, informed and written consent signed by the participant and the investigator Exclusion Criteria: who has a severe wound with suspected open fracture or requiring surgical exploration in the operating room with severe hearing loss or deafness, speech disorders or any acute or chronic condition that compromises listening (at the investigator's discretion), musicogene epilepsy no social security cover unable to decide for himself or herself (at the discretion of the investigator): confused patient, foreign language not understood by the investigator, severe acute intoxication, patient with severe neurological or psychiatric comorbidity under judicial protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie CHARRON
Phone
02 62 35 90 00
Email
mariecharron3@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia BERLY, PhD
Email
laetitia.berly@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thien-Kim DINH, MD
Organizational Affiliation
CHU La Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu DANIEL, MD
Phone
0262 90 55 00
Email
matthieu.daniel2309@gmail.com
First Name & Middle Initial & Last Name & Degree
Matthieu DANIEL, MD
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97410
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thien-Kim DINH, MD
Phone
0262 35 90 00
Email
kim.dinh@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Thien-Kim DINH, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Musicotherapy on Pain During Wound Closure in the Emergency Department

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