Randomised controlled trial on seclusion and mechanical restraint
| ISRCTN | ISRCTN70589121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70589121 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/06/2006
- Registration date
- 25/08/2006
- Last edited
- 10/05/2010
- 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
Prof Tilman Steinert
Scientific
Scientific
ZfP Weissenau
Weingartshoferstr. 2
Ravensburg
88214
Germany
| Phone | +49 (0) 751/7601-2738 |
|---|---|
| tilman.steinert@zfp-weissenau.de |
Study information
| Study design | Cohort design with optional randomisation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | Isofix |
| Study objectives | 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(s) | Ethics approval received from the Ethical Committee of University of Ulm on the 11th November 2002 (amendment approved 20th October 2005) (ref: 136/2002). |
| Health condition(s) or problem(s) studied | Aggressive behaviour or self-directed aggression |
| Intervention | Seclusion and mechanical restraint |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 05/03/2004 |
| Completion date | 05/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/03/2004 |
| Date of final enrolment | 05/03/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
ZfP Weissenau
Ravensburg
88214
Germany
88214
Germany
Sponsor information
University of Ulm (Germany)
University/education
University/education
Department of Psychiatric Health Care Research
Psychiatric Department I
ZfP Weissenau
Weingartshoferstr. 2
Ravensburg
88214
Germany
| Phone | +49 (0) 751/7601-0 |
|---|---|
| tilman.steinert@zfp-weissenau.de | |
| Website | http://www.zfp-web.de/K2/index.php3 |
"ROR" |
https://ror.org/032000t02 |
Funders
Funder type
University/education
University of Ulm (Germany) - Department of Psychiatric Health Care Research
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/01/2010 | Yes | No |
