Wounds InjuriesEMERGENCENCT05388591
Evaluation of Musicotherapy on Pain During Wound Closure in the Emergency Department
A study testing Musicotherapy in people with Wounds Injuries, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds Injuries
- What is being tested?
- Musicotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesReunion
- Study dates
- 14 Jun 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Reunion2 sites
CHU de la Réunion
Saint-Denis, 97400
CHU de la Réunion
Saint-Pierre, 97410
About this study
Official title: 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.
Read the 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.
- Conditions
- Wounds Injuries
- Being tested
- Musicotherapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicotherapyOther
Music listening with the application Music Care (style of music chosen by the patient) during wound suturing
| Study group | Role | What they receive |
|---|---|---|
| Musicotherapy | Experimental | Not described Receives: Other: Musicotherapy |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start14 Jun 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wounds InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thien-Kim DINH, MD, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388591
- Sponsor's protocol ID
- 2022/CHU/10
- Acronym
- EMERGENCE
- Status last verified
- Aug 2025
- First submitted
- 19 May 2022
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charron M, Daniel M, Guihard B, Gokalsing E, Faure L, Bruneau L, Dinh K. Evaluation of a web app-based music intervention on pain during wound closure in the emergency department: The EMERGENCE randomized controlled trial. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101545. doi: 10.1016/j.accpm.2025.101545. Epub 2025 May 21.
PubMed 40409580
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Musicotherapy (Application Music Care) on Pain During Wound Closure in the Emergency Department : a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05388591
- Acronym / sponsor ID
- EMERGENCE / 2022/CHU/10
- Conditions
- Wounds Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Musicotherapy | Experimental | Other: Musicotherapy |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicotherapyMusic listening with the application Music Care (style of music chosen by the patient) during wound suturing | Other | Musicotherapy |
Primary outcome
Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit
Time frame: Day 1
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 40409580Charron M, Daniel M, Guihard B, Gokalsing E, Faure L, Bruneau L, Dinh K. Evaluation of a web app-based music intervention on pain during wound closure in the emergency department: The EMERGENCE randomized controlled trial. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101545. doi: 10.1016/j.accpm.2025.101545. Epub 2025 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thien-Kim DINH, MD principal investigator
CHU La Réunion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musicotherapy in people with Wounds Injuries, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of musicotherapy on maximal pain associated with wound injury closure in emergency unit (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05388591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.