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IRCT20120910010800N17 IRCT 2026-05-19 Shahid Beheshti University of Medical Sciences The role of music therapy in cognitive and emotional rehabilitation in mild traumatic brain injury Music therapy for cognitive and emotional rehabilitation in mild traumatic brain injury: a randomized controlled trial 2026-05-20 anticipated 114 Recruiting https://irct.ir/trial/89941 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After obtaining informed consent and conducting baseline assessments, eligible participants will be randomly assigned to either the music therapy or the control group. The random allocation sequence will be generated using variable block randomization with block sizes of 4 and 6. This sequence will be created by an independent statistician using a computerized random number generator. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be used. Outcome assessors will remain blinded to the patients’ group assignment, Blinding description: In this double-blind, randomized controlled clinical trial, both the participants (patients) and the researchers interacting with the patients (including the investigators providing the training and those conducting clinical follow-ups) will be unaware of group allocation, while the control group receives no intervention other than standard treatment. To achieve this, despite the control group not receiving any intervention, in order to blind the participants, all patients in both groups will be told that "you may be assigned to one of the study groups (music therapy group or comparison group) in the future," without informing the control group that they will not receive any intervention. Additionally, researchers interacting with the patients will not be informed of group allocation, and only an independent individual outside the research team will know which group each patient belongs to. To maintain blinding, all assessment and follow-up sessions will be conducted by researchers who are neither aware of the patient's group nor have had any role in the allocation or intervention implementation process. Finally, the success of blinding will be assessed by asking participants and involved researchers about their guess regarding group allocation. N/A Cognitive and Emotional Rehabilitation of Patients with Traumatic Brain Injury. Intervention 1: Intervention group: Participants in this group, in addition to receiving standard care, will listen daily for one hour (preferably at a fixed and quiet time of the day) to a standardized playlist of instrumental Western classical music using headphones. This intervention will begin on the second or third day of hospital admission and will continue at home for 14 days after discharge. Participants will be provided with a daily logbook to record the time and duration of music listening. The quality of the audio files and the suitability of the headphones will be checked. Intervention 2: Control group: Participants in this group will receive only the usual standard care for mild traumatic brain injury, which may include recommendations regarding rest, symptom management, and a gradual return to activities. No structured music intervention will be provided to them. To control for the attention effect, participants in this group may also be given logbooks to record their daily activities (other than music). Yes - There is a plan to make this available What will be shared: Some portions of the data, such as information related to the primary outcome and similar variables, may be available for sharing. When: One year after the publication of the article To whom: All professions involved in this research Conditions: All non-personal patient information (anonymously) can be accessed by contacting the responsible author. Where to obtain: email to: drdariushabtahi@yahoo.com How to obtain: Sending email and review by the responsible author. Comments:
public Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The ability to understand and implement study instructions Access to a music player and headphones Consent to participate in the study 18 years no limit Both Previous history of moderate or severe TBI Major neurological disorders (e.g., stroke, epilepsy, Parkinson's, MS) Previous severe psychiatric disorders Deafness or significant hearing problems that prevent listening to music Active substance or alcohol abuse Inability to complete the questionnaires (even with assistance) S06.2 Diffuse traumatic brain injury Treatment - Other Placebo Intervention group: Participants in this group, in addition to receiving standard care, will listen daily for one hour (preferably at a fixed and quiet time of the day) to a standardized playlist of instrumental Western classical music using headphones. This intervention will begin on the second or third day of hospital admission and will continue at home for 14 days after discharge. Participants will be provided with a daily logbook to record the time and duration of music listening. The quality of the audio files and the suitability of the headphones will be checked. Control group: Participants in this group will receive only the usual standard care for mild traumatic brain injury, which may include recommendations regarding rest, symptom management, and a gradual return to activities. No structured music intervention will be provided to them. To control for the attention effect, participants in this group may also be given logbooks to record their daily activities (other than music). Cognitive function. Timepoint: At the time of hospital admission (baseline, before initiation of the intervention or allocation), and subsequently at 2 weeks, 1 month, 3 months, 6 months, and 12 months after hospital discharge. Method of measurement: The Cambridge Neuropsychological Test Automated Battery (CANTAB) is an innovative computerized tool designed to assess brain function with precision and reliability. Shahid Beheshti University of Medical Sciences Approved 2025-11-09 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)