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

Traumatic Brain Injury Clinical Trial

— AAT/TBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217030
• Other study ID #: 12-1216
• Status: Completed
• Phase: N/A
• Start date: June 30, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2022
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Inova Fairfax Medical Campus	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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

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

Cole KM, Gawlinski A. Animal-assisted therapy: the human-animal bond. AACN Clin Issues. 2000 Feb;11(1):139-49. — View Citation

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-

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. — View Citation

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. — View Citation

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. Review. — View Citation

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

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

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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