The Effect of Shared Listening to Personalized Music on Symptoms of Behavioral Disorders in the Elderly With Advanced Dementia

March 3, 2020 updated by: 2gether

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MCI patients hospitalised in the research departments
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.
Combination product: 2gether app used by trained personal

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.

Other Names:
  • Listen to random music twice a week for about 40 minutes each time, on personal headphones.
Active Comparator: MCI patients hospitalized in the research departments
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.
Combination product: 2gether app used by trained personal

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.

Other Names:
  • Listen to random music twice a week for about 40 minutes each time, on personal headphones.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in BPSD measure among patients in the department. we use the Neuropsychiatric Inventory (NPI) (Cummings et al., 1994.) which detects changes in BPSD.
Time Frame: 8 month
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.
8 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in the professional caregivers impression of the treatment
Time Frame: 8 month
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.
8 month
change vigor measures of the department's staff (nursing staff)
Time Frame: 8 month
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.
8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
2gether

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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