Pilot study of the short-term effects of a multi-sensory environment (MSE) on elderly patients suffering from depression.

ISRCTN	ISRCTN61466356
DOI	https://doi.org/10.1186/ISRCTN61466356
Secondary identifying numbers	N0081129523

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 28/09/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Sarah Baillon
Scientific

University of Leicester
Psychiatry for the Elderly
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Phone	+44 (0)116 258 4597
Email	sfb5@le.ac.uk

Study information

Study design	Randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Depression
Intervention	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.
Intervention type	Other
Primary outcome measure	1. Hospital Anxiety and Depression Scale (HADS) 2. Beck Depression Inventory (BDI) 3. Visual Analogue Scales of Mood 4. Heart Rate Monitoring
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2003
Completion date	01/05/2005
Reason abandoned (if study stopped)	Lack of facilities

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	12
Key inclusion criteria	12 subjects aged 65+ randomised to intervention or control, with a clinical diagnosis of depressive illness and capacity to give consent.
Key exclusion criteria	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
Date of first enrolment	01/09/2003
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leicester

Leicester
LE5 4PW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Leicestershire Partnership NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan