Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Other: Animal assisted therapy

• Registration Number: NCT05217030
• Lead Sponsor: Inova Health Care Services

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.

Study Timeline

• Study Start: 2014-06-30
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-19
• Status Verified: 2022-02
• Study First Posted: 2022-02-01
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Animal Assisted Therapy	Animal assisted therapy	This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Scale	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	standard measure in acute care for level of consciousness with scale of 3 -15 and 15 being the higher level of consciousness
Rancho Los Amigo Scale	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	standard measure in acute and rehab care for level of consciousness, and for purposes of this study, were measured from 1 to 7 with 7 being reflective of the higher level of consciousness
Level of Commands	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	ability to follow 3-step commands and is used for measure level of cognition with 0 being the lowest and 3 being the score that reflects higher level of consiousness

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Fairfax, Virginia, United States