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

NCT ID: NCT05217030

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Animal Assisted Therapy

This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization

Group Type: EXPERIMENTAL

Animal assisted therapy

Intervention Type: OTHER

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

Control

This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Leslie Horton

RN, CCRN-K, Animal Assisted Care Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leslie Horton, RN, MBA, CCRN

Role: PRINCIPAL_INVESTIGATOR

Inova Health Systems

Locations

Inova Fairfax Medical Campus

Fairfax, Virginia, United States

Countries

United States

References

Brain Trauma Foundation. (2021). It Can Happen Anywhere, Anytime, to Anyone. Retrieved July 2021, Brain_Trauma_Foundation.pdf: http://braintrauma.org

Reference Type: BACKGROUND

Lo J, Chan L, Flynn S. A Systematic Review of the Incidence, Prevalence, Costs, and Activity and Work Limitations of Amputation, Osteoarthritis, Rheumatoid Arthritis, Back Pain, Multiple Sclerosis, Spinal Cord Injury, Stroke, and Traumatic Brain Injury in the United States: A 2019 Update. Arch Phys Med Rehabil. 2021 Jan;102(1):115-131. doi: 10.1016/j.apmr.2020.04.001. Epub 2020 Apr 24.

Reference Type: BACKGROUND

PMID: 32339483 (View on PubMed)

Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.

Reference Type: BACKGROUND

PMID: 31086450 (View on PubMed)

Murthy R, Bearman G, Brown S, Bryant K, Chinn R, Hewlett A, George BG, Goldstein EJ, Holzmann-Pazgal G, Rupp ME, Wiemken T, Weese JS, Weber DJ. Animals in healthcare facilities: recommendations to minimize potential risks. Infect Control Hosp Epidemiol. 2015 May;36(5):495-516. doi: 10.1017/ice.2015.15. No abstract available.

Reference Type: BACKGROUND

PMID: 25998315 (View on PubMed)

Pet Partners. Pet Partners. Retrieved from https://petpartners.org. 2021

Reference Type: BACKGROUND

Osterhoudt, S. R. Animal Assisted Therapy: Improving Patient Outcomes in the ICU. Excelsior College, School of Nursing. 2018

Reference Type: BACKGROUND

Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.

Reference Type: BACKGROUND

PMID: 21632591 (View on PubMed)

Hedrin, M. (2018, 2). Therapy Dogs May Unlock Health Benefits for Patients in Hospital ICUs. Retrieved August 2021, from John Hopkins University: https://hub.jhu.edu/2018/02/12/therapy-dogs-could-help-icu-patients-

Reference Type: BACKGROUND

Abate SV, Zucconi M, Boxer BA. Impact of canine-assisted ambulation on hospitalized chronic heart failure patients' ambulation outcomes and satisfaction: a pilot study. J Cardiovasc Nurs. 2011 May-Jun;26(3):224-30. doi: 10.1097/JCN.0b013e3182010bd6.

Reference Type: BACKGROUND

PMID: 21263346 (View on PubMed)

Cole KM, Gawlinski A. Animal-assisted therapy: the human-animal bond. AACN Clin Issues. 2000 Feb;11(1):139-49. doi: 10.1097/00044067-200002000-00015.

Reference Type: BACKGROUND

PMID: 11040560 (View on PubMed)

Aldaghlas, Tayseer. Burke, Christine. Chang, Yung-Fu. Horton, Leslie. Rizzo, Anne. Richmond, Robyn. Schmidt, Keilla. To Pet or Not: Canine Assisted Therapy and the Risk of Clostridium Difficile. International Conference on Healthcare-Associated Infections. Atlanta, Ga: SHEA/APIC. March 19, 2010. https://shea.confex.com/shea/2010/webprogram/Paper2497.html

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

12-1216

Identifier Type: -

Identifier Source: org_study_id