Contact information
Type
Scientific
Primary contact
Prof Tilman Steinert
ORCID ID
Contact details
ZfP Weissenau
Weingartshoferstr. 2
Ravensburg
88214
Germany
+49 (0) 751/7601-2738
tilman.steinert@zfp-weissenau.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Isofix
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.
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Aggressive behaviour or self-directed aggression
Intervention
Seclusion and mechanical restraint
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Duration of measure, complications and safety.
Overall trial start date
05/03/2004
Overall trial end date
05/03/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
05/03/2004
Recruitment end date
05/03/2006
Locations
Countries of recruitment
Germany
Trial participating centre
ZfP Weissenau
Ravensburg
88214
Germany
Sponsor information
Organisation
University of Ulm (Germany)
Sponsor details
Department of Psychiatric Health Care Research
Psychiatric Department I
ZfP Weissenau
Weingartshoferstr. 2
Ravensburg
88214
Germany
+49 (0) 751/7601-0
tilman.steinert@zfp-weissenau.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Ulm (Germany) - Department of Psychiatric Health Care Research
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20074355
Publication citations
-
Results
Bergk J, Flammer E, Steinert T, "Coercion Experience Scale" (CES)--validation of a questionnaire on coercive measures., BMC Psychiatry, 2010, 10, 5, doi: 10.1186/1471-244X-10-5.