Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06032897

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study was designed to evaluate the effects of Individualized music listening (IML) implemented on older adults with mild cognitive impairment (MCI) and PwD. This quasi-experimental study used convenience sampling where thirty-two elderly individuals were recruited from five community-based dementia care centers then assigned to experimental (EG, n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music in their lives and according to their personal wishes. The EG received eight treatments of IML (two times per week, 20 minutes per time), while the CG received the usual activities of the care centers for four weeks when EG received IML. The anxiety levels of both groups were investigated before and after first time IML and after eighth time IML. The researcher observed positive and negative behaviors of EG before, during and after each IML per 20 minutes in each time IML.

Condition or Disease	Intervention/Treatment	Phase
Music Listening	Other: Individualized music listening (IML)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

The Effect of Personalized Music on the Elderly With Cognitive Impairment and Dementia: a Quasi-experimental Study.

Actual Study Start Date :

Aug 25, 2022

Actual Primary Completion Date :

Jan 5, 2023

Actual Study Completion Date :

Jul 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group The control group who participated in routine activities
Experimental: experimental group The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The individualized music listening were performed twice a week for four weeks, for a total of eight times.	Other: Individualized music listening (IML) The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The Individualized music listening (IML) were performed twice a week for four weeks, for a total of eight times.

Arm

Intervention/Treatment

No Intervention: control group

The control group who participated in routine activities

Experimental: experimental group

The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The individualized music listening were performed twice a week for four weeks, for a total of eight times.

Other: Individualized music listening (IML)

The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The Individualized music listening (IML) were performed twice a week for four weeks, for a total of eight times.

Outcome Measures

Primary Outcome Measures

Anxiety [First day: before the first time individualized music listening; first day: after completing first-time individualized music listeningof 20 minutes; the fourth week: after the last (eighth) time Individualized music listening of 20 minutes.]
The Chinese Mandarin version State-Trait Anxiety Inventory Y form. The scores of the 20 questions are summed with total score ranging from 20 to 80 points. The higher the total score, the higher the anxiety level.
Behavioral [Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.]
The Behavioral Observation Form for Intervention Condition checklist. If the 15 behaviors occurred in each period (20 minutes), the behavior column will be counted as 1 point in this time period, and if there were no behavior, it would be scored as 0 points. In this study, 15 behaviors were further classified into positive and negative behaviors (four negative behaviors included eye movement, agitation/restlessness, alertness, and sleeping), and then the scores of the two types of behaviors were summed up and the total score represented the performances of the behavior type. Higher scores mean more the type.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

50 years or older;
Mild cognitive impairment or dementia.

Exclusion Criteria:

Can not answer questions by themselves;
Have the habit of listening music in the past week.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University	Kaohsiung		Taiwan

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Principal Investigator: Pei-Chao Lin, Kaohsiung Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaohsiung Medical University Chung-Ho Memorial Hospital

ClinicalTrials.gov Identifier:

NCT06032897

Other Study ID Numbers:

KMUHIRB-SV(Ⅰ)-20220050

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital

dementia

individualized music listening

anxiety

behavior

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Sep 13, 2023