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

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

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

Study Overview

• Status: Completed
• Conditions: Sleep; Cognitive Function
• Intervention / Treatment: Device: Music CD

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Using Thai Geriatric Depression Scale (TGDS)	4-week after regularly listening to the music for 28 days
Activities of Daily Living	using AD Cooperative Study Activities of Daily Living Inventory (ADCS/ADL)	4-week after music
Behavior	Using Behavioral pathology in Alzheimer's Disease Rating Scale (BEHAVE AD)	4-week after music
Sleep quality	Using Pittsburgh Sleep Quality Index (PSQI)	4-week after music

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of the care giver's stress and burden	Using visual analog scale	4-week after intervention

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 2, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): January 5, 2011
• Last Update Submitted That Met QC Criteria: January 3, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: dementia; Cognitive function; sleep quality; quality of sleep; Thai traditional music; behavioural problem; psychological health
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: R006h/53