Randomised controlled trial on seclusion and mechanical restraint
| ISRCTN | ISRCTN70589121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70589121 |
| Protocol serial number | N/A |
| Sponsor | University of Ulm (Germany) |
| Funder | University of Ulm (Germany) - Department of Psychiatric Health Care Research |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Cohort design with optional randomisation |
| Secondary study design | Cohort study |
| 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(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. |
| Key secondary outcome measure(s) |
Duration of measure, complications and safety. |
| Completion date | 05/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
