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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317910
• Other study ID #: AIDALZ
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2022
• Source: Association de Musicothérapie Applications et Recherches Cliniques
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• MUSIC CARE
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.

Locations

Country	Name	City	State
France	Sainte-Marie Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association de Musicothérapie Applications et Recherches Cliniques

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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))
Secondary	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