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

NCT ID: NCT01123993

Last Updated: 2011-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Cognitive Function; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle counselling

Group Type: NO_INTERVENTION

Music CD

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neurologist staff, Division of Neurology, Department of medicine, Phramongkutklao Hosptial and College of Medicine

Principal Investigators

Pasiri Sithinamsuwan, MD

Role: PRINCIPAL_INVESTIGATOR

Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand

Sansanee Saengwanitch, MD

Role: STUDY_CHAIR

Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand

Thanawong Yongarnukul

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Tanuphat Tuan-iam

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Kanokporn Wonganankit

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Chananya Potisuk

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Sittichoke Sirimontakan

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Sariya Wongsangsak

Role: STUDY_CHAIR

Phramongkutklao College of Medicine

Akarachaid Pinidbunjerdkool, MD

Role: STUDY_CHAIR

Neurologic Clinic, Division of Neurology, Department of Medicine, Phramongkutklao Hospital, Bangkok, 10400, Thailand

Mathirut Mungthin, MD

Role: STUDY_DIRECTOR

Phramongkutklao College of Medicine

Locations

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

Bangkok, Bangkok, Thailand

Division of Neurology, Phramongkutklao Hospital

Rachatevee, Bangkok, Thailand

Countries

Thailand

Other Identifiers

R006h/53

Identifier Type: -

Identifier Source: org_study_id