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

NCT05217030 | Completed

• 1 other identifier: 12-1216
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

Critical Care; TBI; Animal Assisted Therapy

Outcome Measures

Primary Outcomes (3)

• Glasgow Coma Scale

  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

  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

  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

Study Arms (2)

Animal Assisted Therapy

EXPERIMENTAL

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

Other: Animal assisted therapy

Control

NO INTERVENTION

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

Interventions

Animal assisted therapy 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

Also known as: AAT

Animal Assisted Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Fairfax, Virginia, 22042, United States

Location

Related Publications (11)

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

  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.

  PMID: 32339483 BACKGROUND

• 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.

  PMID: 31086450 BACKGROUND

• 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.

  PMID: 25998315 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 21632591 BACKGROUND

• 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-

  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.

  PMID: 21263346 BACKGROUND

• 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.

  PMID: 11040560 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Leslie Horton, RN, MBA, CCRN

  Inova Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, CCRN-K, Animal Assisted Care Coordinator

Model Details: Two groups of patients had comparison of measurements-one group received AAT; one group did not

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 1, 2022
• Study Start: June 30, 2014
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)