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Clinical Trials/NCT04287452
NCT04287452
Withdrawn
Not Applicable

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

Indiana University1 site in 1 countryMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Acute
Sponsor
Indiana University
Locations
1
Primary Endpoint
Change in salivary cortisol in ED patients with chronic pain
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicholas Pettit

Assistant Professor of Emergency Medicine

Indiana University

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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

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

Outcomes

Primary Outcomes

Change in salivary cortisol in ED patients with chronic pain

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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 Outcomes

  • Change in salivary cortisol levels in emergency department patients(Baseline and T1 (~45 minutes after baseline))

Study Sites (1)

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