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Clinical Trials
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Feasibility of randomized controlled trials on seclusion and mechanical restraint

Jan Bergk

ZfP Weissenau, Department of Psychiatry I, University of Ulm, Weingartshofe str. 2, 88214 Ravensburg, Germany, jan.bergk{at}zfp-weissenau.de

Beate Einsiedler

Institute of Biometrics, University of Ulm, Schwastr, 13, 89075 Ulm, Germany

Tilman Steinert

ZfP Weissenau, Department of Psychiatry I, University of Ulm, Weingartshofe str. 2, 88214 Ravensburg, Germany

Background In psychiatry seclusion and mechanical restraint are most commonly used in the management of violence and self-directed aggression. Both interventions are considered as efficacious and indispensable. Yet, these measures can have deleterious effects on patients. The least restrictive alternative is recommended. Evidence about what kind of intervention is least restrictive is only scarcely available. Up to now, no randomized controlled trial (RCT) on this subject has been conducted.

Purpose To describe ethical, methodological and legal problems of RCTs on coercive interventions and to suggest possible solutions.

Methods Literature research on possible study designs, ethical considerations and legal regulations was conducted in PubMed.

Results Corresponding to the procedures in emergency medicine informed consent can be obtained after the intervention when the patients are capable again. Informed consent refers only to participation in an interview and utilization of data. Randomization can be ethically approved, if exclusion criteria for randomization are defined. A comprehensive cohort study seems to be the most practicable study design. As primary outcome variable an assessment of subjective experiences of the patients' restrictions to human rights. Clinical Trials 2008; 5: 356—363. http://ctjsagepub.com

Clinical Trials, Vol. 5, No. 4, 356-363 (2008)
DOI: 10.1177/1740774508094405
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