Canine-Assisted ANxiety Reduction IN Emergency Care IV

Study Overview
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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.

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

Conditions
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Anxiety Acute, Chronic Pain

Intervention / Treatment
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* Other: Control
* Other: Dog Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* Control<br>|
| Active Comparator: Intervention<br>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<br>* Exposure to certified therapy dogs and their handler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in salivary cortisol levels in emergency department patients | Change in salivary cortisol levels in emergency department patients between baseline and T1 | Baseline and T1 ( 45 minutes after baseline) |