Clinical trial NCT05388591: Evaluation of Musicotherapy on Pain During Wound Closure in the Emergency Department
Official title: Evaluation of Musicotherapy (Application Music Care) on Pain During Wound Closure in the Emergency Department : a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wounds Injuries
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
affiliation: CHU La Réunion
name: Thien-Kim DINH, MD
role: PRINCIPAL_INVESTIGATOR
References: