Group Music Therapy for Acquired Brain Injury

Acquired Brain Injury Clinical Trial

— Meraki_ABI  

Official title:

Meraki: Music Therapy Protocol for People With Acquired Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343662
• Other study ID #: Meraki_Acquired Brain Injury
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Valencia
• Contact: Marián Pérez-Marín, PhD
• Phone: 0034 9639
• Email: marian.perez[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Dr. Moliner	Serra	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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