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

Evaluation of Musicotherapy (Application Music Care) on Pain During Wound Closure in the Emergency Department : a Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds Injuries
• Intervention / Treatment: Other: Musicotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie CHARRON; Phone Number: 02 62 35 90 00; Email: mariecharron3@gmail.com
• Study Contact Backup: Name: Laetitia BERLY, PhD; Email: laetitia.berly@chu-reunion.fr

Study Locations

• Réunion
  • Saint-Denis, Réunion, 97400
    • Recruiting
    • CHU de la Réunion
    • Contact: Matthieu DANIEL, MD; Phone Number: 0262 90 55 00; Email: matthieu.daniel2309@gmail.com
    • Principal Investigator: Matthieu Daniel, MD
  • Saint-Pierre, Réunion, 97410
    • Recruiting
    • CHU de la Réunion
    • Contact: Thien-Kim DINH, MD; Phone Number: 0262 35 90 00; Email: kim.dinh@chu-reunion.fr
    • Principal Investigator: Thien-Kim DINH, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Musicotherapy	Other: Musicotherapy; Music listening with the application Music Care (style of music chosen by the patient) during wound suturing
No Intervention: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Thien-Kim DINH, MD, CHU La Réunion

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Wounds and Injuries
• Other Study ID Numbers: 2022/CHU/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No