Canine-Assisted ANxiety Reduction IN Emergency Care IV

Not Applicable

Withdrawn

• Conditions: Chronic Pain; Anxiety Acute
• Interventions: Other: Control; Other: Dog Therapy

• Registration Number: NCT04287452
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Study Start: 2022-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Intervention	Dog Therapy	Emergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in salivary cortisol levels in emergency department patients	Baseline and T1 (~45 minutes after baseline)	Change in salivary cortisol levels in emergency department patients between baseline and T1

Trial Locations

Locations (1)

Eskenazi Health System; 🇺🇸 Indianapolis, Indiana, United States