Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients
Evaluation of Effect of Music Therapy on Anxiety of Carers of Alzheimer's Disease Patients
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Apr 2022
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2022
CompletedJuly 27, 2022
July 1, 2022
4 months
March 13, 2022
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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 Arms (1)
Music intervention
EXPERIMENTALMusic intervention (duration 20 minutes) every day for 30 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1
- Patient relationship (child, spouse, brother/sister)
You may not qualify if:
- Presence of a psychiatric disorder
- Intellectual disability
- Major hearing loss
- Professional musician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sainte-Marie Hospital
Paris, 75014, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2022
First Posted
April 8, 2022
Study Start
April 1, 2022
Primary Completion
July 20, 2022
Study Completion
July 20, 2022
Last Updated
July 27, 2022
Record last verified: 2022-07