A randomized clinical trial to compare the use of safety net enclosures with standard restraints in agitated hospitalized patients

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. Journal of Hospital Medicine 2007;2:385–393. © 2007 Society of Hospital Medicine.