Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)

February 18, 2022 updated by: Leslie Horton, Inova Health Care Services

Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Animal Assisted Therapy
This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization
Other: Animal assisted therapy
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 Names:
  • AAT
NO_INTERVENTION: Control
This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Coma Scale
Time Frame: 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
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
Rancho Los Amigo Scale
Time Frame: 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
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
Level of Commands
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Leslie Horton, RN, MBA, CCRN, Inova Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2014

Primary Completion (ACTUAL)

November 30, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (ACTUAL)

February 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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