A study of the long-term and short-term efects of Snoezelen and Reminiscence therapy on patients suffering from dementia who have associated agitated behavior problems

ISRCTN	ISRCTN60367715
DOI	https://doi.org/10.1186/ISRCTN60367715
Secondary identifying numbers	N0081063463

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 30/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Sarah Baillon
Scientific

Psychiatry for the Elderly
University of Leicester
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 trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	What effect does Snoezelen have on the behaviour and physiological responses of people with dementia who exhibit agitated behaviour, and how do these effects compare to those resulting from a more traditional form of therapy, such as Reminiscence? As of 28/07/09 the target number of participants was updated from "not provided at time of registration" to 20 as detailed in 2004 results.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Dementia
Intervention	Comparative group study. Subjects randomly allocated to one of two groups. Each group will receive an initial introductory Snoezelen session after initial baseline assessments and observations. Group 1 will then receive three Snoezelen sessions over 2 weeks, 1 week without intervention and then three reminiscence sessions over a further 2 weeks. Group 2 will follow the same pattern, but will have reminiscence therapy first.
Intervention type	Other
Primary outcome measure	1. Heart rate reduction 2. Frequency of observed agitated behaviour (Agitated Behaviour Mapping Instrument) after each session 3. Frequency of agitated behaviour (Cohen-Mansfield Agitation Inventory) after each intervention and at 2-week follow-up
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/2000
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	20 (8 male, 12 female) (added 28/07/09)
Key inclusion criteria	1. Subjects will have dementia and be reported by staff as exhibiting significant agitated behaviour, known to psychiatric services and either day patients or on an organic assessment ward. 2. No age limit will be applied but the range is expected to be between 55-85.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/02/2000
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Psychiatry for the Elderly

Leicester
LE5 4PW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2004		Yes	No