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
Protocol serial number N0081063463
Sponsor Department of Health (UK)
Funder Leicestershire Partnership NHS Trust (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesWhat 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) studiedMental and Behavioural Disorders: Dementia
InterventionComparative 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration20
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/02/2000
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Psychiatry for the Elderly
Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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