ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Effects of Music Interventions on Hospitalised People With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00448318
Recruitment Status : Unknown
Verified February 2007 by National Ageing Research Institute, Australia.
Recruitment status was:  Not yet recruiting
First Posted : March 16, 2007
Last Update Posted : March 16, 2007
Sponsor:
Information provided by:
National Ageing Research Institute, Australia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities.

Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success.

Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention.

The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do.

In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.


Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Dementia, Vascular Lewy Body Disease Procedure: Music Therapy Phase 2 Phase 3

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
Study Start Date : March 2007
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mini Mental State Examination: baseline cf. post intervention scores.
  2. Hierarchic Dementia Scale: baseline cf. post intervention scores.
  3. Geriatric Depression Scale: baseline cf. post intervention scores.
  4. Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Secondary Outcome Measures :
  1. EEG fast/slow ratio: baseline cf. post intervention scores.
  2. EEG Coherence: baseline cf. post intervention scores.
  3. EEG evoked potentials:baseline cf. post intervention scores.
  4. Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of dementia

Exclusion Criteria:

  • delirium
  • acute medical conditions (eg pneumonia, cardiac failure)
  • primary psychiatric conditions (eg schizophrenia)
  • severe hearing impairment
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448318


Contacts
Contact: Jonathan B Barber, PhD +61 3 8387 2638 b.barber@nari.unimelb.edu.au
Contact: John W Barlow, PhD +61 3 83872296 j.barlow@nari.unimelb.edu.au

Locations
Australia, Victoria
National Ageing Research Institute Not yet recruiting
Parkville, Victoria, Australia, 3052
Contact: John W Barlow, PhD    +61 3 8387 2296      
Principal Investigator: Jonathan B Barber, PhD         
Sponsors and Collaborators
National Ageing Research Institute, Australia
Investigators
Principal Investigator: Jonathan B Barber, PhD National Ageing Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00448318     History of Changes
Other Study ID Numbers: WKG_07_BB
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: March 16, 2007
Last Verified: February 2007

Keywords provided by National Ageing Research Institute, Australia:
Controlled clinical trial

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Lewy Body Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases