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Canine-Assisted ANxiety Reduction IN Emergency Care IV

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04287452
Acronym
CANINE IV
Enrollment
0
Registered
2020-02-27
Start date
2022-03-01
Completion date
2022-12-31
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Acute, Chronic Pain

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.

Interventions

OTHERControl

Control

Exposure to certified therapy dogs and their handler.

Sponsors

Healthcare Initiatives, Inc.
CollaboratorUNKNOWN
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in salivary cortisol in ED patients with chronic painBaseline and T1 (~45 minutes after baseline)Change in salivary cortisol levels in emergency department patients between baseline and T1
Morphine equivalent narcotic administration in emergency department patients with chronic painDate of enrollment until emergency department discharge, up to 72 hoursTotal morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.
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
Change in salivary cortisol in ED patients with emotional crisisBaseline 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 crisisDate of enrollment until emergency department discharge, up to 72 hoursNumber of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis
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

MeasureTime frameDescription
Change in salivary cortisol levels in emergency department patientsBaseline and T1 (~45 minutes after baseline)Change in salivary cortisol levels in emergency department patients between baseline and T1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026