Music therapy for cognitive and emotional rehabilitation in mild traumatic brain injury: a randomized controlled trial

To evaluate the effectiveness of listening to instrumental Western classical music on improving cognitive function and mood, and reducing post‑concussion symptoms in patients with mild traumatic brain injury.

A phase II randomized, double‑blind, parallel‑group controlled clinical trial in 100 patients; allocation to music therapy or control groups using variable block randomization.

After informed consent, patients ≥18 years old with mild traumatic brain injury admitted to Imam Hossein Hospital will be enrolled and randomly assigned to music therapy or control groups using variable block randomization. The intervention group will listen to instrumental classical music for 1 hour daily until 14 days after discharge, while the control group will receive standard care only. Assessments will be performed at admission and at 2 weeks, 1, 3, 6, and 12 months after discharge.

Patients ≥18 years old with an initial diagnosis of mild traumatic brain injury admitted to general wards. Inclusion criteria: ability to understand and follow study instructions, access to a music player and headphones, and willingness to participate in follow‑up. Exclusion criteria: prior TBI, major neurological disease, severe psychiatric disorder, significant hearing impairment, active substance or alcohol abuse, or inability to complete questionnaires.

Intervention group: In addition to standard care, patients will listen to instrumental Western classical music with headphones for 1 hour daily from day 2–3 of hospitalization until 14 days after discharge and record it. Control group: Patients will receive standard care only

The Cambridge Neuropsychological Test Automated Battery (CANTAB)

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.

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.

Some portions of the data, such as information related to the primary outcome and similar variables, may be available for sharing.

One year after the publication of the article

All professions involved in this research

All non-personal patient information (anonymously) can be accessed by contacting the responsible author.

email to: drdariushabtahi@yahoo.com

Sending email and review by the responsible author.