Skip to content

Randomised controlled trial on seclusion and mechanical restraint

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN70589121
Enrollment
220
Registered
2006-08-25
Start date
2004-03-05
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive behaviour or self-directed aggression Mental and Behavioural Disorders Personality disorder

Interventions

Seclusion and mechanical restraint

Sponsors

University of Ulm (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Duration of measure, complications and safety.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026