Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;

• decrease reported anxiety levels in emergency department (ED) patients,
• decrease salivary cortisol in ED patients,
• decrease total morphine equivalent dosing in the emergency department or at discharge and/or,
• decrease reported stress levels in emergency department providers caring for participating patients

when compared to usual care.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Pain; Anxiety Acute
• Intervention / Treatment: Other: Control; Other: Dog Therapy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate L Pettit; Phone Number: 3178803870; Email: klpettit@iu.edu
• Study Contact Backup: Name: Courtney Linville; Phone Number: 317-880-3877; Email: ctlinvil@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients

• Age 18-89 years
• Chronic pain, defined as pain on most days for >6 weeks
• Triage pain score >6 out of 10

OR

• Age 18-89 years
• Currently experience crisis, including suicidality, or
• Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale

Providers

• Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.

Therapy Dog Handlers

• Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program

Exclusion Criteria:

Patients

• Violent behavior
• Overt intoxication
• Non-English speaking
• Any reported prior fear or adverse reaction to dogs

Providers

• Any reported prior fear or adverse reaction to dogs

Therapy Dog Handlers

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Emergency department patients enrolled in the control arm will receive usual care. Emergency department providers enrolled in the control arm will work their shift as usual.	Other: Control; Control
Active Comparator: Intervention; Emergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler	Other: Dog Therapy; Exposure to certified therapy dogs and their handler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine equivalent narcotic administration in emergency department patients with chronic pain	Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.	Date of enrollment until emergency department discharge, up to 72 hours
Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)	Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol in ED patients with chronic pain	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis	Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis	Date of enrollment until emergency department discharge, up to 72 hours
Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)	Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1	Baseline and T1 (~45 minutes after baseline)
Change in salivary cortisol in ED patients with emotional crisis	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in salivary cortisol levels in emergency department patients	Change in salivary cortisol levels in emergency department patients between baseline and T1	Baseline and T1 (~45 minutes after baseline)

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Healthcare Initiatives, Inc.

Publications and helpful links

General Publications

• Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21.
• Munoz Lasa S, Maximo Bocanegra N, Valero Alcaide R, Atin Arratibel MA, Varela Donoso E, Ferriero G. Animal assisted interventions in neurorehabilitation: a review of the most recent literature. Neurologia. 2015 Jan-Feb;30(1):1-7. doi: 10.1016/j.nrl.2013.01.012. Epub 2013 May 1. English, Spanish.
• Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.
• Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.
• Havey J, Vlasses F, Vlasses P, Ludwig P, Hackbarth D. The Effect of Animal-Assisted Therapy on Pain Medication Use After Joint Replacement. Anthrozoos 2014; 27: 361-369.
• Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
• Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014 Oct 14;14:219. doi: 10.1186/1472-6920-14-219.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2022
• Primary Completion (Estimated): December 31, 2022
• Study Completion (Estimated): December 31, 2022

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Chronic Pain; Anxiety Disorders
• Other Study ID Numbers: 001968358

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