Clinical trial NCT05217030: Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury
Official title: Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Critical Care
TBI
Animal Assisted Therapy
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients had comparison of measurements-one group received AAT; one group did not
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Admitted to Trauma ED with GCS \< 10 due to Traumatic Brain Injury via head CT scan and/or head MRI
* Primary language is Spanish or English
* Free of Infection Precautions
* No canine allergies or fears
* Consent to Study Obtainable

Exclusion Criteria:

* Not meeting inclusion criteria (n=58)

  * Declined to participate (n=21)
  * No next of kin for consent (n=147)
  * Unsurvivable injury (n=83)

Primary outcomes:
measure: Glasgow Coma Scale
timeFrame: measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
measure: Rancho Los Amigo Scale
timeFrame: measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
measure: Level of Commands
timeFrame: measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
Study officials:
affiliation: Inova Health Systems
name: Leslie Horton, RN, MBA, CCRN
role: PRINCIPAL_INVESTIGATOR
References:
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