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

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

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.

Study Overview

• Status: Completed
• Conditions: Music Listening
• Intervention / Treatment: Other: Individualized music listening (IML)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 50 years or older;
2. Mild cognitive impairment or dementia.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Pei-Chao Lin, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): January 5, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: dementia; anxiety; behavior; individualized music listening
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: KMUHIRB-SV(Ⅰ)-20220050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No