Clinical trial NCT05317910: Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients
Official title: Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Music intervention
Alzheimer
Anxiety
Lead sponsor: Association de Musicothérapie Applications et Recherches Cliniques
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline STAI score at 28 days
timeFrame: Day 1 and Day 28
Secondary outcomes:
measure: Change on EVA score immediately after each session
timeFrame: Before and immediately after each session (up to 28 days (one session every day))
measure: Change from baseline STAI score at 15 days
timeFrame: Day 1 and Day 15
Other outcomes:
Locations:
city: Paris
country: France
facility: Sainte-Marie Hospital
Study officials:
References: