Canine-Assisted ANxiety Reduction IN Emergency Care IV

NCT04287452 | Withdrawn

• 1 other identifier: 001968358
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Acute; Chronic Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Change in salivary cortisol levels in emergency department patients

  Baseline and T1 (~45 minutes after baseline)

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

ACTIVE COMPARATOR

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

Interventions

Control OTHER

Control

Control

Dog Therapy OTHER

Exposure to certified therapy dogs and their handler.

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Healthcare Initiatives, Inc.: collaborator

Study Sites (1)

Eskenazi Health System

Indianapolis, Indiana, 46202, United States

Location

Related Publications (7)

• 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.

  PMID: 19341990 BACKGROUND

• 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.

  PMID: 23170993 BACKGROUND

• 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.

  PMID: 9634160 BACKGROUND

• 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.

  PMID: 23642347 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27002161 BACKGROUND

• 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.

  PMID: 25315848 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 27, 2020
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)