Canine-Assisted Anxiety Reduction In Emergency Care

Study Overview
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Brief Summary
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Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. We will also measure galvanic skin response (resistance to electrical current).

Detailed Description
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This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient stress. The organization Paws of Love estimates that it has 180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer their time in emergency care. The benefits may include improved perception of wellness, less opioid use, and decreased use of physical and chemical restraints. As a further extrapolation, this secondary effect may extend to improved patient-doctor communication and patient experience. This will in turn improve patient safety in the Emergency Department, decreasing the number of adverse events, and decreasing the risk of medical malpractice by improving the patient-provider relationship. (6, 7)

Official Title
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Canine-Assisted Anxiety Reduction In Emergency Care

Conditions
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Anxiety, Opioid Use, Children, Therapy Dog

Intervention / Treatment
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* Behavioral: Dog + handler
* Behavioral: No dog


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-17 years old; Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety Exclusion Criteria: - violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be randomized per dog and handler availability, but subjects that are excluded due to an aversion or dogs or per the Child Life staff member, can be in the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dog + handler<br> | Behavioral: Dog + handler<br>* Dog + handler<br>|
| Placebo Comparator: No dog<br> | Behavioral: No dog<br>* No dog<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety level of subject | Change in anxiety level of subject with the use of the FACES scale | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of anxiety level from physician | Change in perception anxiety level of subject with the use of the FACES scale | 60 minutes | 
| Perception of pain level from physician | Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale | 60 minutes | 
| Perception of anxiety level from parent(s) | Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale | 60 minutes | 
| Perception of pain level from parent(s) | Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale | 60 minutes | 
| Meds | Number of medications used to reduce anxiety in the different arms | 4 hours | 
| Physical restrain use | Number of times physical restraints are used | 4 hours |