NCT06032897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

August 28, 2023

Last Update Submit

September 4, 2023

Conditions

Keywords

dementiaindividualized music listeninganxietybehavior

Outcome Measures

Primary Outcomes (2)

  • Anxiety

    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.

    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.

  • Behavioral

    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.

    Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.

Study Arms (2)

control group

NO INTERVENTION

The control group who participated in routine activities

experimental group

EXPERIMENTAL

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)

Interventions

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.

experimental group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older;
  • Mild cognitive impairment or dementia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

DementiaAnxiety DisordersBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Pei-Chao Lin

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 13, 2023

Study Start

August 25, 2022

Primary Completion

January 5, 2023

Study Completion

July 3, 2023

Last Updated

September 13, 2023

Record last verified: 2023-08

Locations