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.


METHODS
Single-centered randomized controlled trial.


METHODS
Community hospital.


METHODS
Agitated hospitalized patients requiring restraint.


METHODS
Patients were randomized to either standard restraints or the safe enclosure. We used the SOMA Safe Enclosure.


METHODS
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.
Nawaz
Haq
H
Department of Internal and Preventive Medicine, Griffin Hospital, Derby, Connecticut 06418, USA. hnawaz@griffinhealth.org
Abbas
Atif
A
Sarfraz
Asif
A
Slade
Martin D
MD
Calvocoressi
Lisa
L
Wild
Dorothea M G
DM
Tessier-Sherman
Baylah
B
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011482:Protective Devices / Q000009:adverse effects / Q000706:statistics & numerical data*; D011595:Psychomotor Agitation / Q000453:epidemiology* / Q000451:nursing / Q000628:therapy; D012149:Restraint, Physical / Q000009:adverse effects / Q000706:statistics & numerical data*