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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00448318




Registration number
NCT00448318
Ethics application status
Date submitted
14/03/2007
Date registered
16/03/2007
Date last updated
16/03/2007

Titles & IDs
Public title
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
Scientific title
Evaluating the Effects of Music Interventions on Hospitalised People With Dementia
Secondary ID [1] 0 0
WKG_07_BB
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Alzheimer's Disease 0 0
Dementia, Vascular 0 0
Lewy Body Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Music Therapy

Treatment: Surgery: Music Therapy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mini Mental State Examination: baseline cf. post intervention scores.
Timepoint [1] 0 0
Primary outcome [2] 0 0
Hierarchic Dementia Scale: baseline cf. post intervention scores.
Timepoint [2] 0 0
Primary outcome [3] 0 0
Geriatric Depression Scale: baseline cf. post intervention scores.
Timepoint [3] 0 0
Primary outcome [4] 0 0
Note: post intervention measures taken within 24 hours of final therapeutic intervention session
Timepoint [4] 0 0
Secondary outcome [1] 0 0
EEG fast/slow ratio: baseline cf. post intervention scores.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
EEG Coherence: baseline cf. post intervention scores.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
EEG evoked potentials:baseline cf. post intervention scores.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Note: post intervention measures taken within 24 hours of final therapeutic intervention session
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Clinical diagnosis of dementia
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- delirium

- acute medical conditions (eg pneumonia, cardiac failure)

- primary psychiatric conditions (eg schizophrenia)

- severe hearing impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Ageing Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
National Ageing Research Institute, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00448318
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan B Barber, PhD
Address 0 0
National Ageing Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jonathan B Barber, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8387 2638
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00448318