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.: PACTR202508478849170 Date of Registration: 26/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Music Therapy in Reducing Pain in Patients with Thoracic Trauma: A Randomized Controlled Trial
Official scientific title Effectiveness of Music Therapy in Reducing Pain in Patients with Thoracic Trauma: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Thoracic trauma is a common reason for admission to intensive care units and represents the second leading cause of mortality among polytrauma patients. Pain management in thoracic trauma patients presents a major challenge in medicine due to the complexity of associated pain and the potential side effects of pharmacological treatments. Effective analgesia is a crucial pillar in the management of these patients.Music therapy, as a non-pharmacological intervention, has shown promising effects in managing pain and anxiety in various clinical settings. However, its specific efficacy in thoracic trauma patients remains underexplored, particularly as an adjunct to pharmacological therapies. The objectives of the study is to evaluate the effect of music therapy on pain and anxiety management in patients with thoracic trauma hospitalized in the Department of Anesthesia and Intensive Care at Sahloul University Hospital.
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2024
Actual trial start date 01/08/2024
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group musictherapy the patient listened to music for 30 minutes the second day of hospitalization 30 minutes the patient listened to music for 30 minutes the second day of hospitalization The music was selected by the patient from a validated playlist (relaxing music, without lyrics, slow tempo, 60–80 bpm). Listening was done through sterile headphones, in a semi-sitting position, in a quiet environment. 34
Control Group control group 30 minutes patients in the control group wore headphones without music, lying comfortably in a semi-sitting position on their bed, with dimmed lighting and the room temperature set at 26°C. 34 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age over 18 years Glasgow Coma Scale score greater than or equal to 13 Having agreed to participate in the study Being able to communicate Patients who did not complete the session 80 and over: 80+ Year,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 16/11/2024 the Ethics Committee of the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evolution of pain intensity measured by the Numeric Rating Scale (NRS) from 0 to 10 Before the session,Immediately after and 30 minutes after the session 30 minutes
Secondary Outcome evolution of Respiratory rate evolution of Oxygen saturation (SpO₂) evolution of Heart rate Analgesic requirements (amount of morphine or equivalent) Anxiety assessment (score using STAI or visual analogue scale for anxiety) Patient satisfaction with care 30 minutes after the session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
sahloul hospital route de ceinture sousse 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
salma melayah avenue commandant bejaoui sousse 4000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor salma melayah avenue commandant bejaoui sousse 4000 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator salma melayah salma.melayah@outlook.com +21652903275 avenue commandant bejaoui
City Postal code Country Position/Affiliation
sousse Tunisia mediacal doctor
Role Name Email Phone Street address
Public Enquiries hela ghali hela.ghali@outlook.com +21696590973 sahloul
City Postal code Country Position/Affiliation
sousse Tunisia medical doctor
Role Name Email Phone Street address
Scientific Enquiries farouk jdidi FaroukJdidi@hotmail.com +21629295540 hammam sousse
City Postal code Country Position/Affiliation
sousse Tunisia medical doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No particular Individual participant data will be available nor shared. You may find the study protocol available. All data will be available upon data collection and analysis which will be made anonymously. Results will be published in the form of an article as well as the study protocol. Study Protocol one year Controlled upon request
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