Condition category
Mental and Behavioural Disorders
Date applied
06/06/2006
Date assigned
25/08/2006
Last edited
10/05/2010
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

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

http://www.zfp-web.de/K2/index.php3

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

  1. 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.

Additional files

Editorial Notes