Condition category
Mental and Behavioural Disorders
Date applied
27/02/2018
Date assigned
04/04/2018
Last edited
04/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The increasing prevalence of dementia raises the question of how the quality of life and care for people with dementia can be maintained and enhanced. Previous research shows that listening to personally meaningful music can promote positive emotions and memories as well as a reduction of stress, agitation, and anxiety of people with dementia. Thus, individualized music can be regarded as a promising, non-drug intervention for people with dementia. This study investigates whether listening to individualized music improves quality of life, well-being, social participation and reduces problem behavior of people with dementia. It aims at evaluating the effectiveness, applicability, and acceptance of an individualized music intervention for people with dementia in institutional care.

Who can participate?
People with dementia living in one of the cooperating nursing homes

What does the study involve?
Participants are randomly allocated to an intervention group or a control group. Over a period of 6 weeks, participants in the intervention group listen to their individualized music playlist every other day for 20 minutes. The control group participants receive standard care. In this period of time, observation of behavior is conducted for both groups every other week for 60 minutes. External assessments by the nursing staff are conducted at four assessment points regarding well-being, social participation, problem behavior, and daily behavior of the people with dementia.

What are the possible benefits and risks of participating?
The possible benefits of listening to individualized music include improvement of quality of life and a reduction of problem behavior of people with dementia. The intervention is expected to enhance well-being, quality of sleep and social participation as well as reduce agitation and resistance to care. A possible risk of participating is that agitated behavior increases temporarily in response to the music selected for the individualized playlists. However, project staff or staff from the nursing home monitor the participants and intervene if a negative reaction is observable during the music intervention.

Where is the study run from?
The study is being run by the Department of Counseling and Clinical Intervention, Institute of Psychology, Friedrich-Schiller University Jena. It takes place in four to five nursing homes in Thuringia (Germany).

When is the study starting and how long is it expected to run for?
January 2018 to July 2020

Who is funding the study?
National Association of Statutory Health Insurance Funds (Germany)

Who is the main contact?
Prof. Dr. Gabriele Wilz

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gabriele Wilz

ORCID ID

Contact details

Humboldtstraße 11
Jena
07743
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS00013793

Study information

Scientific title

Individualized music for people with dementia - Improvement of quality of life and social participation for people with dementia in institutional care

Acronym

Study hypothesis

The trialists expect an improvement of quality of life and a reduction of problem behavior (e.g. agitation, resistance to care) for the participating people with dementia in the intervention group compared with the control group. Quality of life includes well-being, quality of sleep and social participation.
In addition, they expect to observe positive short-term effects during and after the music intervention: emotional and motor changes (facial expression, body movement and other positive reactions) and an enhancement of communication, attention and orientation.

Ethics approval

Ethical Commission of the Faculty of Social and Behavioural Sciences, 20/02/2018, ref: FSV 18/06

Study design

Multicenter randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Dementia

Intervention

Participants are randomly allocated to an intervention or a control group.

Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week for 60 minutes before, during and after the music intervention.

The control group receives standard care. The observation of behavior will be conducted with the same frequency and duration as in the intervention group.

External assessments by the nursing staff will be conducted at four assessment points regarding well-being, social participation, problem behavior, and daily behavior of the people with dementia. baseline (6 weeks before treatment), pretest, posttest, follow-up (6 weeks after the treatment)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Quality of life:
1.1. External assessment by the nursing staff at all four assessment points: mood, sleep quality, social participation (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), depressive symptoms (assessed with the Cornell Scale for Depression in Dementia, CSDD)
1.2. Observation of behavior will be conducted three times during the intervention period using an adapted rating scale: emotional and motor changes (facial expression, body movement, other (positive) reactions), activation regarding social participation

2.Problem behavior:
2.1. External assessment by the nursing staff at all four assessment points: resistance to care (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), problem behavior/behavioral syndromes (assessed with the Cohen-Mansfield Agitation Inventory (CMAI) and the Nurses Observation Scale for Geriatric Patients (NOSGER II)
2.2. Observation of behavior (see above): appearance of problem behavior or other negative reactions

Measured at baseline (6 weeks before treatment), pretest, posttest, follow-up (6 weeks after the treatment)

Secondary outcome measures

Acceptance and applicability of the intervention measured using a self-developed questionnaire at posttest

Overall trial start date

01/01/2018

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of dementia
2. Living in institutional care
3. Informed consent provided by the participants themselves, their relatives or their conservator

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Severe hearing problems
2. No informed consent provided by the participants themselves, their relatives or their conservator

Recruitment start date

15/01/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Germany

Trial participating centre

Friedrich-Schiller-Universität Jena, Abteilung Klinisch-psychologische Intervention
Humboldtstraße 11
Jena
07743
Germany

Sponsor information

Organisation

Friedrich-Schiller-Universität Jena

Sponsor details

Institut für Psychologie
Abteilung Klinisch-psychologische Intervention
Humboldtstraße 11
Jena
07743
Germany

Sponsor type

University/education

Website

http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html

Funders

Funder type

Other

Funder name

National Association of Statutory Health Insurance Funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be submitted for publication on 15/04/2018. Planned publication of the results in high-impact peer-reviewed journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Lisette Weise (lisette.weise@uni-jena.de).

Intention to publish date

31/07/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes