Group Music Therapy for Acquired Brain Injury

NCT06343662 | Terminated

• 1 other identifier: Meraki_Acquired Brain Injury
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acquired Brain Injury

Keywords

music therapy-based treatment; psychological intervention; discomfort; Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Barthel Index

  Baseline

• Pfeiffer Short Form Mental State Questionnaire, SPMSQ

  Baseline

• Charlson Comorbidity Index (CCI),

  Baseline

Study Arms (2)

No Intervention: Control Group

NO INTERVENTION

Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).

Experimental group

EXPERIMENTAL

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

Interventions

MERAKI_ABI BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital Dr. Moliner

Serra, Valencia, Spain

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marián Pérez-Marín, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 18, 2026

Record last verified: 2024-12

Locations

ES (1)