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ISRCTN
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ISRCTN61466356
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ClinicalTrials.gov identifier
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Public title
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Pilot study of the short-term effects of a multi-sensory environment (MSE) on elderly patients suffering from depression.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0081129523
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Study hypothesis
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This is a pilot study. The main aim of which is to assess the appropriateness of the recruitment criteria, feasibility of the schedule of measures and the acceptability of the measures to the subjects.
A secondary aim is to identify whether there are any large effects of the interventions which may be useful in refining the methodology of the definitive study.
Multi-Sensory Environments (MSE) are widely used in paediatrics, pain clinics, maternity facilities and in the care of the elderly with dementia. Studies have shown improvements in mood, enjoyment and levels of boredom, with increased relaxation and reduced agitation. Anecdotal evidence on the benefits of MSE in depression in the elderly points to a potential benefit which should be explored.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled pilot study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Depression
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Participants - inclusion criteria
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12 subjects aged 65+ randomised to intervention or control, with a clinical diagnosis of depressive illness and capacity to give consent.
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Participants - exclusion criteria
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1. Organic brain syndrome
2. Significant hearing impairment
3. Significant sight impairment
4. Suicidal ideation
5. Electroconvulsive therapy (ECT) during course of trial
6. Evidence of delirium or change in psychotropis medication will trigger withdrawal
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/05/2005
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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12
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Interventions
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1. Intervention Group (two one-to-one sessions in the MSE over one week)
2. Control Group (two one-to-one relaxation sessions over one week)
Added 21 August 2008: This trial was stopped because the facilities required to carry out the research (i.e. the multi-sensory environment) were closed and no other alternatives were available locally.
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Primary outcome measure(s)
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1. Hospital Anxiety and Depression Scale (HADS)
2. Beck Depression Inventory (BDI)
3. Visual Analogue Scales of Mood
4. Heart Rate Monitoring
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Leicestershire Partnership NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Miss
Sarah
Baillon
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Address
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University of Leicester
Psychiatry for the Elderly
Leicester General Hospital
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 4597
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Fax
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+44 (0)116 273 1115
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Email
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sfb5@le.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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28/09/2011
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Date ISRCTN assigned
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30/09/2004
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