Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Patients admitted to the ED with moderate to severe traumatic brain injury defined by GCS
      less than or equal to 10 and confirmed by head CT scan or MRI were randomized into 2 groups:
      one receiving animal assisted therapy (AAT) and one not receiving animal assisted therapy.
      Efficacy of AAT was measured by patient's progression in the Glasgow Coma Scale (GCS), Rancho
      Los Amigos Scale (RLAS), and ability to follow multi-step commands (LoCmds).
    

Detailed description: 
      In this Level 3 prospective, randomized case control basic research study, investigators
      compared 2 groups, randomly assigned: patients receiving AAT during their hospital stay and
      those patients receiving usual care. Investigators recruited adult patients admitted to the
      TICU with a severe or moderate TBI; patients' legally authorized representatives provided
      consent for patients to be randomized into an intervention or control group. Patients were
      randomized to the intervention or control group in a 1:1 ratio; the randomization schedule
      was generated in advance by the study biostatistician utilizing a permuted block method with
      block sizes of 2 or 4. Study subjects' assigned groups were indicated on paper in a sealed
      envelope that was opened by the researchers upon receipt of signed informed consent form.

      Investigators hypothesized the subjects in the intervention group would achieve higher
      elevation in Glasgow Coma Scale (GCS), Ranchos Los Amigos Scale (RLAS), and ability to follow
      commands than those in the control group. GCS, RLAS, and Levels of Command (LOCmd) scores
      were recorded by the bedside nurse for enrolled patients within 24 hours of consent. LOCmds
      were determined by the number of commands a patient could follow without prompting in between
      the commands. Subjects unable to follow any commands scored "0"; those able to follow one
      command scored "1," and so on, up to 3 commands without prompting. Intervention patients then
      received AAT with a dog, followed by the collection of post-intervention scores. The bedside
      RN assisted the handler in placing the dog onto the patient's bed and the patient was
      informed the dog was present. The patient's hand was placed on the dog and then the patient
      was instructed to open eyes and/or follow commands. The bedside RN assessed and the recorded
      the patient's responses before and after each AAI. Control patients' second set of scores
      were recorded after a researcher sat in the room without engaging the patient. The bedside RN
      assessed and recorded the patient before and after each control intervention. AAT and control
      activities, with associated data collection,continued every Monday, Wednesday, and Friday
      following initial measurements. Subjects remained enrolled in the study through discharge, or
      until the subject was recorded at RLAS 7, or until hospitalized over 28 days. Patients
      discharged from the study, but remaining in the hospital, were able to continue receiving
      AAT.
    

Intervention name(s): Animal assisted therapy
Intervention type(s): Other
Intervention description(s): Patients in AAT group had handler place dog on bed and patient's hand was placed on dog. Bedside RN measured GCS, RLAS, LoCmds before and after intervention
Other intervention name(s): AAT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of patients had comparison of measurements-one group received AAT; one group did not
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical Care; TBI; Animal Assisted Therapy