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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

This study has been completed.
Sponsor:
Information provided by:
Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier:
NCT01123993
First received: May 2, 2010
Last updated: January 3, 2011
Last verified: January 2011
History of Changes
  Purpose

To determine the effect of Thai traditional music on cognitive function, psychological health and quality of sleep among Thai older individuals with dementia.


Condition Intervention Phase
Cognitive Function
Sleep
 Device: Music CD
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Thai Traditional Music on Cognitive Function, Psychological Health and Quality of Sleep Among Thai Older Individuals With Dementia.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Phramongkutklao College of Medicine and Hospital:

Primary Outcome Measures:
  • Depression [ Time Frame: 4-week after regularly listening to the music for 28 days ] [ Designated as safety issue: No ]
    Using Thai Geriatric Depression Scale (TGDS)

  • Activities of Daily Living [ Time Frame: 4-week after music ] [ Designated as safety issue: No ]
    using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)

  • Behavior [ Time Frame: 4-week after music ] [ Designated as safety issue: No ]
    Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)

  • Sleep quality [ Time Frame: 4-week after music ] [ Designated as safety issue: No ]
    Using Pittsburgh Sleep Quality Index (PSQI)


Secondary Outcome Measures:
  • reduction of the care giver's stress and burden [ Time Frame: 4-week after intervention ] [ Designated as safety issue: No ]
    Using visual analog scale


Estimated Enrollment: 60
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lifestyle counselling Device: Music CD
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123993

Locations
Thailand
Division of Neurology, Phramongkutklao Hospital
Rachatevee, Bangkok, Thailand, 10400
Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
Principal Investigator: Pasiri Sithinamsuwan, MD Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Study Chair: Sansanee Saengwanitch, MD Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Study Chair: Thanawong Yongarnukul Phramongkutklao College of Medicine
Study Chair: Tanuphat Tuan-iam Phramongkutklao College of Medicine
Study Chair: Kanokporn Wonganankit Phramongkutklao College of Medicine
Study Chair: Chananya Potisuk Phramongkutklao College of Medicine
Study Chair: Sittichoke Sirimontakan Phramongkutklao College of Medicine
Study Chair: Sariya Wongsangsak Phramongkutklao College of Medicine
Study Chair: Akarachaid Pinidbunjerdkool, MD Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand
Study Director: Mathirut Mungthin, MD Phramongkutklao College of Medicine
  More Information

No publications provided

Responsible Party: Dr.Pasiri Sithinamsuwan, Neurologist staff, Division of Neurology, Department of medicine, Phramongkutklao Hosptial and College of Medicine
ClinicalTrials.gov Identifier: NCT01123993     History of Changes
Other Study ID Numbers: R006h/53
Study First Received: May 2, 2010
Last Updated: January 3, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Phramongkutklao College of Medicine and Hospital:
Thai traditional music
dementia
Cognitive function
behavioural problem
 sleep quality
psychological health
quality of sleep

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013