Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MUSIC CARE
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Music intervention, Alzheimer, Anxiety
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
Sites / Locations
- Sainte-Marie Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music intervention
Arm Description
Music intervention (duration 20 minutes) every day for 30 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05317910
First Posted
March 13, 2022
Last Updated
July 26, 2022
Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
1. Study Identification
Unique Protocol Identification Number
NCT05317910
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Music intervention, Alzheimer, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music intervention
Arm Type
Experimental
Arm Description
Music intervention (duration 20 minutes) every day for 30 days
Intervention Type
Other
Intervention Name(s)
MUSIC CARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline STAI score at 28 days
Description
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.
Time Frame
Day 1 and Day 28
Secondary Outcome Measure Information:
Title
Change on EVA score immediately after each session
Description
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.
Time Frame
Before and immediately after each session (up to 28 days (one session every day))
Title
Change from baseline STAI score at 15 days
Description
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.
Time Frame
Day 1 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Sainte-Marie Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients
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