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Randomised controlled trial on seclusion and mechanical restraint
ISRCTN ISRCTN70589121
DOI 10.1186/ISRCTN70589121
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial on seclusion and mechanical restraint
Scientific title
Acronym Isofix
Serial number at source N/A
Study hypothesis There is a difference in the subjective assessment of patients regarding the restriction of human rights after seclusion or mechanical restraint was being conducted.
Lay summary
Ethics approval Ethics approval received from the Ethical Committee of University of Ulm on the 11th November 2002 (amendment approved 20th October 2005) (ref: 136/2002).
Study design Cohort design with optional randomisation
Countries of recruitment Germany
Disease/condition/study domain Aggressive behaviour or self-directed aggression
Participants - inclusion criteria 1. Patients for whom coercive measures are indicated
2. Diagnosis F2, F3 or F6 in International Classification of Diseases (ICD-10)
3. Informed consent
Participants - exclusion criteria 1. Severe intellectual deficits
2. Continously severely disturbed mental state
3. Poor German
4. Inclusion into study during a former admission
5. Missing informed consent
6. Exclusion Criteria to randomisation:
a. definite wish of the patient not to receive one but the other measure
b. contraindication to one measure by the psychiatrist
Anticipated start date 05/03/2004
Anticipated end date 05/03/2006
Status of trial Completed
Patient information material
Target number of participants 220
Interventions Seclusion and mechanical restraint
Primary outcome measure(s) Subjective assessment of patients' restrictions of a human rights score composed of human dignity, autonomy, freedom of movement, interpersonal contact and perceived coercion during conducting the measure.
Secondary outcome measure(s) Duration of measure, complications and safety.
Sources of funding University of Ulm (Germany) - Department of Psychiatric Health Care Research
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20074355
Contact name Prof  Tilman  Steinert
  Address ZfP Weissenau
Weingartshoferstr. 2
  City/town Ravensburg
  Zip/Postcode 88214
  Country Germany
  Tel +49 (0) 751/7601-2738
  Fax +49 (0) 751/7601-2767
  Email tilman.steinert@zfp-weissenau.de
Sponsor University of Ulm (Germany)
  Address Department of Psychiatric Health Care Research
Psychiatric Department I
ZfP Weissenau
Weingartshoferstr. 2
  City/town Ravensburg
  Zip/Postcode 88214
  Country Germany
  Tel +49 (0) 751/7601-0
  Fax +49 (0) 751/7601-2767
  Email tilman.steinert@zfp-weissenau.de
  Sponsor website: http://www.zfp-web.de/K2/index.php3
Date applied 06/06/2006
Last edited 10/05/2010
Date ISRCTN assigned 25/08/2006
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