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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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]

WKG_07_BB

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Alzheimer's Disease

Dementia, Vascular

Lewy Body Disease

Condition category

Condition code

Neurological

Alzheimer's disease

Neurological

Dementias

Mental Health

Other mental health disorders

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Mini Mental State Examination: baseline cf. post intervention scores.

Timepoint [1]

Primary outcome [2]

Hierarchic Dementia Scale: baseline cf. post intervention scores.

Timepoint [2]

Primary outcome [3]

Geriatric Depression Scale: baseline cf. post intervention scores.

Timepoint [3]

Primary outcome [4]

Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Timepoint [4]

Secondary outcome [1]

EEG fast/slow ratio: baseline cf. post intervention scores.

Timepoint [1]

Secondary outcome [2]

EEG Coherence: baseline cf. post intervention scores.

Timepoint [2]

Secondary outcome [3]

EEG evoked potentials:baseline cf. post intervention scores.

Timepoint [3]

Secondary outcome [4]

Note: post intervention measures taken within 24 hours of final therapeutic intervention session

Timepoint [4]

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?

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

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

UNKNOWN

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]

National Ageing Research Institute - Parkville

Recruitment postcode(s) [1]

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/study/NCT00448318

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Jonathan B Barber, PhD

Address

National Ageing Research Institute

Country

Phone

Fax

Contact person for public queries

Name

Jonathan B Barber, PhD

Address

Country

Phone

+61 3 8387 2638

Fax

b.barber@nari.unimelb.edu.au

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00448318

Trial Review

Registering a new trial?

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