Canine-Assisted ANxiety Reduction IN Emergency Care IV

NCT ID: NCT04287452

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Acute Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Control

Intervention

Emergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler

Group Type ACTIVE_COMPARATOR

Dog Therapy

Intervention Type OTHER

Exposure to certified therapy dogs and their handler.

Interventions

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Control

Control

Intervention Type OTHER

Dog Therapy

Exposure to certified therapy dogs and their handler.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Healthcare Initiatives, Inc.

UNKNOWN

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Pettit

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eskenazi Health System

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19341990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23170993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9634160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23642347 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 27002161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25315848 (View on PubMed)

Other Identifiers

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001968358

Identifier Type: -

Identifier Source: org_study_id

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