Reducing physical restraints in psycho-geriatric nursing home residents

ISRCTN ISRCTN10117742
DOI https://doi.org/10.1186/ISRCTN10117742
Secondary identifying numbers NL592, NTR648
Submission date
07/06/2006
Registration date
07/06/2006
Last edited
08/01/2021
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

Ms Anna Huizing
Scientific

University Maastricht (UM)
Department of Health Care Studies
Section of Nursing Science
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3881545
Email a.huizing@zw.unimaas.nl

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleReducing physical restraints in psycho-geriatric nursing home residents
Study objectivesIt is hypothesized that an educational intervention will lead to a reduction of restraint use in psycho-geriatric nursing home residents.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPhysical restraint use
InterventionThe educational intervention consists of an educational programme combined with consultation with a nurse specialist. The educational intervention is designed to comply with the decision-making process concerning restraint use defined in a Dutch guideline for restraint use in care situations and to cause nurses to embrace a philosophy of restraint-free care and be familiar with techniques of individualized care. Nurses in the experimental group attended the educational programme on restraint use. Furthermore, consultation with a nurse specialist was introduced on the experimental wards. There was no educational intervention in the control group and residents received the normal care.
Intervention typeOther
Primary outcome measure1. Restraint prevalence: the percentage of residents observed restrained at any time during the 24-hour period
2. Restraint intensity: the number of times in four observations that a particular resident is restrained
3. Restraint types: restraint types used in residents
4. Multiple restraint: the number of different restraint types used per resident recorded during the four observations
Secondary outcome measures1. Residents' characteristics, like demographic characteristics, cognitive status, self performance in activities of daily living, mobility, fall incidence, fall-related injuries and psycho-active drug use
2. Organisational characteristics, like workload of nurses and staffing level on the wards
Overall study start date01/09/2003
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants400
Total final enrolment432
Key inclusion criteriaPsycho-geriatric nursing home residents
Key exclusion criteriaNursing home residents suffering from Korsakov’s disease or psychiatric diseases are excluded
Date of first enrolment01/09/2003
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

University of Maastricht (UM) (The Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

University/education

University of Maastricht (UM), Province of Limburg, The Netherlands

No information available

Meander Care Group (Zorggroep Meander Oostelijk Zuid-Limburg, the Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2009 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.