Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients

Study 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.

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

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: MUSIC CARE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music intervention<br>Music intervention (duration 20 minutes) every day for 30 days | Other: MUSIC CARE<br>* Relaxation-type receptive musical intervention technique. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to relaxation using the new U-Mount technique [1, 2] (Figure 1). 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) is followed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline STAI score at 28 days | 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. | Day 1 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on EVA score immediately after each session | Short-term anxiety will be evaluated by a Visual Analogue Scale (VAS) with a score from 0 to 10, which assesses caregiver anxiety, with higher scores correlating with greater anxiety. | Before and immediately after each session (up to 28 days (one session every day)) | 
| Change from baseline STAI score at 15 days | 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. | Day 1 and Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music intervention, Alzheimer, Anxiety