title: A randomized clinical trial to compare the use of safety net enclosures with standard restraints in agitated hospitalized patients.
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.
  
  
  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.
authors: Department of Internal and Preventive Medicine, Griffin Hospital, Derby, Connecticut 06418, USA. hnawaz@griffinhealth.org
authors: Haq
authors: H
authors: Nawaz
authors: Atif
authors: A
authors: Abbas
authors: Asif
authors: A
authors: Sarfraz
authors: Martin D
authors: MD
authors: Slade
authors: Lisa
authors: L
authors: Calvocoressi
authors: Dorothea M G
authors: DM
authors: Wild
authors: Baylah
authors: B
authors: Tessier-Sherman
mesh_terms: 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*