Group Music Therapy for Acquired Brain Injury (Meraki_ABI)

Meraki: Music Therapy Protocol for People With Acquired Brain Injury

The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.

Study Overview

• Status: Terminated
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: MERAKI_ABI

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Serra, Valencia, Spain
      • Hospital Dr. Moliner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index > 60).
• Be over 18 years of age.
• The participant or their relatives have signed the informed consent form.
• They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.

Exclusion Criteria:

• Failure to obtain informed consent
• The Barthel Index score is below 60, indicating functional dependency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention: Control Group; Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental: Experimental group; Patients admitted to the brain injury unit will participate in a music therapy protocol starting one week after admission. Prior to the group session, three evaluations will be conducted over six days. Post-treatment assessments will also be conducted to enable longitudinal evaluation of the patient over the course of a week.	Behavioral: MERAKI_ABI; The music therapy session will focus on the themes of reidentification and involvement. The aim is to accompany the patient during the illness process, allowing them to express their emotional state, relate to music, promote listening and communication between family members, help and value preserved abilities, and promote personal involvement in the rehabilitation process. The session will work with songs, taking into account musical preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Discomfort ( Baseline (3 Assessments), Pre- Post)	The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. It consists of nine items that evaluate factors such as noisy breathing, body language, facial expressions, and verbalizations. Each observation is scored dichotomously (0-1, presence-absence), resulting in a score range of 0 to 9. A higher score indicates less discomfort. The language used is clear, concise, and objective, adhering to formal register and precise word choice. The text is grammatically correct and follows conventional structure and formatting features.	Baseline up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	The purpose of this assessment is to evaluate the patient's functional independence. It involves assessing their ability to perform 10 activities of daily living, including eating, washing, dressing, grooming, bowel movements, urination, toileting, transferring, ambulation, and stair use. The scores range from 0, indicating maximum dependence, to 100, indicating maximum independence.	Baseline
Pfeiffer Short Form Mental State Questionnaire, SPMSQ	This assessment evaluates cognitive impairment through a series of 10 questions that explore orientation, remote and working memory, as well as calculation skills. Each incorrectly answered question adds one point, and more than 2 errors suggest the presence of cognitive impairment that requires further study.	Baseline
Charlson Comorbidity Index (CCI),	This tool predicts the one-year mortality rate for patients with various comorbid conditions, including heart disease, AIDS, and cancer (a total of 8 conditions in the short version). The measure assigns a score to each condition based on the associated risk of death. A score of 0 to 1 indicates no comorbidity, 2 points indicates low comorbidity, and 3 points or more indicates high comorbidity. The total score predicts mortality.	Baseline

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Marián Pérez-Marín, PhD, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: discomfort; psychological intervention; Acquired Brain Injury; music therapy-based treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: Meraki_Acquired Brain Injury

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No