The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2gether app used by trained personal
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring music therapy
Eligibility Criteria
Inclusion Criteria:
- Hospitalized in the Department of Mental Disorders at the Mental Health Center in Be'er Sheva aged 18 and over.
- Patients who have been diagnosed with dementia for the issue.
- Patients whose guardian gave consent for the study.
Exclusion Criteria:
- Hearing-impaired patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCI patients hospitalised in the research departments
MCI patients hospitalized in the research departments
Arm Description
each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes.
each of the elderly in the control group will Listen to random music twice a week for about 40 minutes each time, on personal headphones.
Outcomes
Primary Outcome Measures
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD.
the measured scale estimates 10 out of 12 common behavioural disorders in Dementia: delusions, hallucinations, depression, anxiety, agitation, aggression, euphoria, inhibitions, irritability or instability, , Abnormal motor activity. A higher score indicates a larger severity of these behaviours. min-0 max-140. The follow-up will be performed by a nurse in both departments on a weekly basis during 8 months of the study.
Secondary Outcome Measures
change in the professional caregivers impression of the treatment
We will use a global improvement subclass. This is a scale of 7 points, "1" - the situation has improved greatly and "7" - the situation has worsened greatly.
change vigor measures of the department's staff (nursing staff)
burnout is a common challenge among caregivers of dementia patients. we use Shirom-Melamed Vigor Measure (SMVM) tool. a 12-item tool with a minimum score indicating a higher incidence of wear.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04293263
Brief Title
The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
Official Title
The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
2gether
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 study is of great importance because it uses a method that has not been tested in the past. To date, various interventions have been examined that use music for patients with dementia. At the same time, no intervention was conducted that integrates an additional person who shares personalized music with the patient.
If the combination of another person who shares the positive effect of the music with the patient is found to enhance the positive effect of the music, it can change the routine of work with dementia patients and may even reduce the use of tranquilizers among them.
In many cases, it has been found that one of the biggest challenges for family members who treat patients with dementia is the lack of content in the sessions and as a result, the growing sense of alienation between the patient and his family.
Listening to music can be a significant tool in the hands of the family, the main caregiver, the medical staff, and any person who comes in contact with the patient, a tool that can strengthen the sense of connection and connection between them.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
music therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MCI patients hospitalised in the research departments
Arm Type
Experimental
Arm Description
each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes.
Arm Title
MCI patients hospitalized in the research departments
Arm Type
Active Comparator
Arm Description
each of the elderly in the control group will Listen to random music twice a week for about 40 minutes each time, on personal headphones.
Intervention Type
Combination Product
Intervention Name(s)
2gether app used by trained personal
Other Intervention Name(s)
Listen to random music twice a week for about 40 minutes each time, on personal headphones.
Intervention Description
each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes.
Musical partner - A person trained in the program's work plan, which includes contact with empathic listening and the use of a dedicated application developed for it. A musical partner will meet with the same elderly person throughout the study period.
Empathetic listening - a situation in which a person listens to music with another person, while the music enables contact and deepening the connection between people.
Primary Outcome Measure Information:
Title
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD.
Description
the measured scale estimates 10 out of 12 common behavioural disorders in Dementia: delusions, hallucinations, depression, anxiety, agitation, aggression, euphoria, inhibitions, irritability or instability, , Abnormal motor activity. A higher score indicates a larger severity of these behaviours. min-0 max-140. The follow-up will be performed by a nurse in both departments on a weekly basis during 8 months of the study.
Time Frame
8 month
Secondary Outcome Measure Information:
Title
change in the professional caregivers impression of the treatment
Description
We will use a global improvement subclass. This is a scale of 7 points, "1" - the situation has improved greatly and "7" - the situation has worsened greatly.
Time Frame
8 month
Title
change vigor measures of the department's staff (nursing staff)
Description
burnout is a common challenge among caregivers of dementia patients. we use Shirom-Melamed Vigor Measure (SMVM) tool. a 12-item tool with a minimum score indicating a higher incidence of wear.
Time Frame
8 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized in the Department of Mental Disorders at the Mental Health Center in Be'er Sheva aged 18 and over.
Patients who have been diagnosed with dementia for the issue.
Patients whose guardian gave consent for the study.
Exclusion Criteria:
Hearing-impaired patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oron Azulay, MA
Phone
972525402281
Email
oron@2gether.fun
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia
We'll reach out to this number within 24 hrs