Clinical trial NCT04287452: Canine-Assisted ANxiety Reduction IN Emergency Care IV
Official title: Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety Acute
Chronic Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Healthcare Initiatives, Inc.
First posted: 2020-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Morphine equivalent narcotic administration in emergency department patients with chronic pain
timeFrame: Date of enrollment until emergency department discharge, up to 72 hours
measure: Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)
timeFrame: Baseline and T1 (~45 minutes after baseline)
measure: Change in salivary cortisol in ED patients with chronic pain
timeFrame: Baseline and T1 (~45 minutes after baseline)
measure: Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
timeFrame: Date of enrollment until emergency department discharge, up to 72 hours
measure: Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)
timeFrame: Baseline and T1 (~45 minutes after baseline)
measure: Change in salivary cortisol in ED patients with emotional crisis
timeFrame: Baseline and T1 (~45 minutes after baseline)
Secondary outcomes:
measure: Change in salivary cortisol levels in emergency department patients
timeFrame: Baseline and T1 (~45 minutes after baseline)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health System
state: Indiana
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.