Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202504789125308 Date of Registration: 03/04/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Music Therapy for Acute Pain and Anxiety in Prehospital Care
Official scientific title Evaluating Music Therapy for Acute Pain and Anxiety Relief in Road Traffic Accident Victims During Prehospital Care: A Randomized Controlled Trial Protocol
Brief summary describing the background and objectives of the trial Road traffic accidents (RTAs) represent a significant cause of global morbidity and mortality. Pre-hospital emergency medical services (EMS) are crucial for initial patient stabilization. Optimal pain and anxiety control in the immediate post-traumatic phase is essential but often suboptimal in RTA patients. Music therapy (MT) has been shown to be an effective non-pharmacological modality for pain and anxiety reduction in acute medical settings. However, its utility within the pre-hospital EMS response to RTAs requires further investigation. This study evaluates MT as an adjunct to standard prehospital care for pain and anxiety in RTA patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2025
Actual trial start date
Anticipated date of last follow up 30/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Standard Care with Music Therapy 20 min Participants in the intervention group will receive standard prehospital care for RTAs from the EMS team, including pharmacological pain management and routine nursing care, supplemented by a single 20-minute MT session.Music will be delivered via headphones. A pre-selected playlist curated by an experienced and certified music therapist will be used. 48
Control Group Standard Care Only 20 min Participants in the control group will receive standard care without musicotherapy. To maintain allocation concealment and minimize bias, they will also wear headphones for the same 20-minute duration, but without any audio playback. 48 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be included in this study, the patient must: - Be an adult (≥ 18 years old) - Have a sustained injuries due to a RTA, - Be capable of understanding and providing informed consent, and - Experience moderate to severe pain (ie; VAS score ≥ 4 - The patients present with hemodynamic instability or an immediate life-threatening condition requiring urgent intervention, - The patients need sedation or intubation, - Unscheduled medical or ethical concerns will compromise participation - The duration of the EMS intervention is less than 20 minutes - Active psychotic disorder or severe cognitive impairment affecting consent comprehension, - Severe hearing impairment preventing effective communication, - Pregnancy, - Previous use of analgesics within the past 24 hours, and - Explicit refusal to participate 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/03/2025 Medical Ethics committee of the Faculty of medicine IBN EL JAZZAR of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui SOUSSE 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain reduction measured using a 100-mm visual analogue scale 5 minutes, 10 minutes, 20 minutes and upon arrival at the hospital
Secondary Outcome anxiety levels (assessed using the beck anxiety inventory at baseline, 20 minutes post-intervention, and upon hospital arrival), changes in respiratory and cardiovascular parameters (heart rate, systolic and diastolic blood pressure, respiratory rate, partial oxygen saturation) (at 5 minutes, 10 minutes, 20 minutes, and upon hospital arrival), and patient satisfaction (assessed upon arrival). 0 min, 5 minutes, 10 minutes, 20 minutes, and upon hospital arrival
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ESM 03 The emergency medical service of the East Center route de la Ceinture 4054 Sousse Sahloul - SOUSSE. Sousse Sahloul 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul university Hospital rte de la Ceinture Sousse Sahloul 4054 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sahloul University Hospital rte de la Ceinture 4054 Sousse Sahloul Sousse Sahloul 4054 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Imen Ben Saida imen.bensaida@yahoo.com +21622897096 Rue Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Associate professor
Role Name Email Phone Street address
Public Enquiries Imen Ben Saida imen.bensaida@yahoo.com +21622897096 Rue Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Associate professor
Role Name Email Phone Street address
Scientific Enquiries Imen Ben Saida imen.bensaida@yahoo.com +21622897096 Rue Ibn El Jazzar
City Postal code Country Position/Affiliation
Sousse 4000 Tunisia Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes Individual participant data (text, tables, figures, and appendices), after de-identification, will be available for sharing starting one year after publication and with no end date. Individuals and organizations engaged in scientific or scholarly research can request these details by contacting imen.bensaida@yahoo.com to further their approved research proposals. Clinical Study Report,Study Protocol one year Access the IPD and related documents will be vailable to researchers and organizations conducting scientific or scholarly research.Interested parties should submit a formal request by email to imen.bensaida@yahoo.com. The request should include purpose of data use, analysis plan, and specific needs. All requests will be assessed based on the following criteria : requester qualifications, scientific merit, data sharing benefits and ethical considerations. The documents, including study protocols, statistical details, and other relevant materials, will be made available as agreed upon.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 26/03/2025 Changed at the reviewer's request Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year