Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study
Primary Purpose
Music Listening
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Individualized music listening (IML)
Sponsored by
About this trial
This is an interventional health services research trial for Music Listening focused on measuring dementia, individualized music listening, anxiety, behavior
Eligibility Criteria
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.
Sites / Locations
- Kaohsiung Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
The control group who participated in routine activities
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06032897
First Posted
August 28, 2023
Last Updated
September 4, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06032897
Brief Title
Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study
Official Title
The Effect of Personalized Music on the Elderly With Cognitive Impairment and Dementia: a Quasi-experimental Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
July 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Listening
Keywords
dementia, individualized music listening, anxiety, behavior
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group who participated in routine activities
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized music listening (IML)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
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.
Title
Behavioral
Description
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.
Time Frame
Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Chao Lin
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study
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