ABSTRACT
BACKGROUND: Although hospitals attempt to minimize the use of restraints, certain cases require their application. For such patients, there is a need for novel, safe and more humane restraint systems. OBJECTIVE: To assess the acceptability and efficacy of safe enclosures in agitated hospitalized patients. DESIGN: Single-centered randomized controlled trial. SETTING: Community hospital. PATIENTS: Agitated hospitalized patients requiring restraint. INTERVENTION: Patients were randomized to either standard restraints or the safe enclosure. We used the SOMA Safe Enclosure. MEASUREMENTS: Perception scores of relatives, physicians, and nurses; agitation scores of patients (assessed using the Agitated Behavior Scale (ABS) and the Alcohol Withdrawal Assessment Form (AWAF)); length of stay; time in restraints; total dose of medication used to treat agitation; and injuries. RESULTS: Of the 49 patients randomized, 20 were assigned to the safe enclosure group and 29 were assigned to the standard restraint group. Relatives, physicians and secondary nurses rated the safe enclosure more positively than standard restraints (P < .001, P < .001, P = .023, respectively). There was no difference between groups in level of agitation (AWA at 48 hours, P = .8516; ABS at 48 hours, P = .3743); length of stay (P = .3077); time in restraints (P = .5745);or total dose of medication (anti-anxiety medications, P = .5607; anti-psychotic medications, P = .7858). There was one injury to a patient in the standard restraint group and none in the safe enclosure group. CONCLUSIONS: For hospitalized patients requiring restraint, the SOMA Safe Enclosure is effective and more acceptable to relatives, physicians, and secondary nurses than currently used restraints.
