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Clinical Trials/NCT05317910
NCT05317910
Completed
Not Applicable

Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients

Association de Musicothérapie Applications et Recherches Cliniques1 site in 1 country26 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Enrollment
26
Locations
1
Primary Endpoint
Change from baseline STAI score at 28 days
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

Detailed Description

This clinical trial evaluates the impact of music on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day hospital "Memory and Frailty " (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital. All participants will benefit from a first session of a relaxation-type musical technique in the Day care Hospital (HDJ), they will then follow the sessions in their own homes. During the first visit, all participants will complete self-assessments, including a questionnaire on musical preferences and a self-assessment anxiety scale. The expected inclusion period is 30 days. Carers will be equipped with tablets, headphones, eye masks and workbooks/questionnaires to use every day for one month in their homes. A relaxation-type receptive musical technique is used. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to a state of relaxation using the new U technique. The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") follows. All the musical sequences, built with the U-shape editing method, were specially produced by the music publishing company Music Care©. During the first session in HDJ, the subjects will lie on a relaxation table with a raised headrest (extended or semi-seated listening position) in an enclosed space, calm, secure and comfortable, with minimum lighting, so that the participant feels comfortable. The music will be played on headphones. The main objective is to reduce anxiety among carers who accompany patients with memory disorders, Alzheimer's disease and related dementia.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
July 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1
  • Patient relationship (child, spouse, brother/sister)

Exclusion Criteria

  • Presence of a psychiatric disorder
  • Intellectual disability
  • Major hearing loss
  • Professional musician

Outcomes

Primary Outcomes

Change from baseline STAI score at 28 days

Time Frame: Day 1 and Day 28

Long-term anxiety will be measured using the State Trait Anxiety Inventory (STAI) scale. The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Secondary Outcomes

  • Change on EVA score immediately after each session(Before and immediately after each session (up to 28 days (one session every day)))
  • Change from baseline STAI score at 15 days(Day 1 and Day 15)

Study Sites (1)

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