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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
2gether
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring music therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 16, 2020
    Last Updated
    March 3, 2020
    Sponsor
    2gether
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    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

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