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The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia

Primary Purpose

Cognitive Function, Sleep

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Music CD
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Function focused on measuring Thai traditional music, dementia, Cognitive function, behavioural problem, sleep quality, psychological health, quality of sleep

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 60 years
  • Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10
  • No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study
  • CD player available at home
  • Patient and care giver consent to study

Exclusion Criteria:

  • Severe depression requiring aggressive treatment or hospitalization
  • Dementia with Lewy body, multisystem atrophy
  • Treatable dementia
  • Active medical problems
  • Profound hearing loss

Sites / Locations

  • Division of Neurology, Phramongkutklao Hospital
  • Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Lifestyle counselling

Arm Description

Outcomes

Primary Outcome Measures

Depression
Using Thai Geriatric Depression Scale (TGDS)
Activities of Daily Living
using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)
Behavior
Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)
Sleep quality
Using Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

reduction of the care giver's stress and burden
Using visual analog scale

Full Information

First Posted
May 2, 2010
Last Updated
January 3, 2011
Sponsor
Phramongkutklao College of Medicine and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01123993
Brief Title
The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia
Official Title
The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.
Detailed Description
Dementia, regardless of its cause, has been recognized to be one of the most important and common problems among the elderly worldwide. The prevalence of dementia has been increasing gradually throughout the world. It is associated with medical and psychological consequences, especially in the advanced stage of the condition. Medications for dementia, specifically, acetylcholine esterase inhibitors, have proven efficacy but variable individual response. They are very expensive and stress families and insurance payers. Dementia and its neuropsychiatric co-morbidities effects not only individual patients, but also family members and care givers as it stresses interpersonal relationships, increases the need for personal care, nursing home placement, and the use of neuropsychiatric medications. Any new approach to improve cognitive function, behavior, mood and sleep quality among demented individuals therefore could have far reaching benefits for patients, care givers, financially responsive parties, and the country as a whole. There are several studies focusing on the non-pharmacologic approaches to care of the demented. The objectives were to reduce reliance on prescribed medications with these adjunctive therapies. One of the interesting non-drug trials was about music therapy. It was found that music could improve behavioral and social functions among individual demented patients. However, the methodology of each music study varied considerably. To our knowledge, there has been no music study in dementia performed in Thailand using our unique Thai traditional music. We therefore aim to study this non-pharmacologic approach in Thai demented individuals using Thai traditional music. We hypothesized that regular listening to Thai traditional music will improve cognitive function, activities of daily living, mood, behavior and sleep quality in Thai demented patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Sleep
Keywords
Thai traditional music, dementia, Cognitive function, behavioural problem, sleep quality, psychological health, quality of sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counselling
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Music CD
Intervention Description
During 4-week interventional period of each group, a researcher gives a CD to care giver and advises him/her to open the music for patient for at least 60 minutes daily, after dinner to bedtime. Meanwhile, the care giver notes the exact duration that patient actually listens to it in the calendar provided and returns the CD and document to the researcher at the end of interventional period.
Primary Outcome Measure Information:
Title
Depression
Description
Using Thai Geriatric Depression Scale (TGDS)
Time Frame
4-week after regularly listening to the music for 28 days
Title
Activities of Daily Living
Description
using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)
Time Frame
4-week after music
Title
Behavior
Description
Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)
Time Frame
4-week after music
Title
Sleep quality
Description
Using Pittsburgh Sleep Quality Index (PSQI)
Time Frame
4-week after music
Secondary Outcome Measure Information:
Title
reduction of the care giver's stress and burden
Description
Using visual analog scale
Time Frame
4-week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 60 years Diagnosed with Alzheimer's disease, vascular dementia or mixed dementia by ICD-10 No change in neuropsychiatric drugs for at least 4-week before and 8-week during the study CD player available at home Patient and care giver consent to study Exclusion Criteria: Severe depression requiring aggressive treatment or hospitalization Dementia with Lewy body, multisystem atrophy Treatable dementia Active medical problems Profound hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasiri Sithinamsuwan, MD
Organizational Affiliation
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sansanee Saengwanitch, MD
Organizational Affiliation
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thanawong Yongarnukul
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tanuphat Tuan-iam
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kanokporn Wonganankit
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chananya Potisuk
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sittichoke Sirimontakan
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sariya Wongsangsak
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Akarachaid Pinidbunjerdkool, MD
Organizational Affiliation
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mathirut Mungthin, MD
Organizational Affiliation
Phramongkutklao College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Division of Neurology, Phramongkutklao Hospital
City
Rachatevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia

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