Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sarah Baillon

ORCID ID

Contact details

Psychiatry for the Elderly
University of Leicester
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4597
sfb5@le.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0081063463

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2000

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

20 (8 male, 12 female) (added 28/07/09)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2000

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychiatry for the Elderly
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Leicestershire Partnership NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15481068
2. 2005 results in http://www.ingentaconnect.com/content/cot/bjot/2005/00000068/00000008/art00005

Publication citations

  1. Results

    Baillon S, Van Diepen E, Prettyman R, Redman J, Rooke N, Campbell R, A comparison of the effects of Snoezelen and reminiscence therapy on the agitated behaviour of patients with dementia., Int J Geriatr Psychiatry, 2004, 19, 11, 1047-1052, doi: 10.1002/gps.1208.

Additional files

Editorial Notes