Canine-Assisted Anxiety Reduction In Emergency Care (CANINE III)
Primary Purpose
Anxiety, Opioid Use, Children
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dog + handler
No dog
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
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.
Sites / Locations
- IU Health Riley Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dog + handler
No dog
Arm Description
Outcomes
Primary Outcome Measures
Change in anxiety level of subject
Change in anxiety level of subject with the use of the FACES scale
Secondary Outcome Measures
Perception of anxiety level from physician
Change in perception anxiety level of subject with the use of the FACES scale
Perception of pain level from physician
Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale
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
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
Meds
Number of medications used to reduce anxiety in the different arms
Physical restrain use
Number of times physical restraints are used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03784573
Brief Title
Canine-Assisted Anxiety Reduction In Emergency Care
Acronym
CANINE III
Official Title
Canine-Assisted Anxiety Reduction In Emergency Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Opioid Use, Children, Therapy Dog
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dog + handler
Arm Type
Active Comparator
Arm Title
No dog
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dog + handler
Intervention Description
Dog + handler
Intervention Type
Behavioral
Intervention Name(s)
No dog
Intervention Description
No dog
Primary Outcome Measure Information:
Title
Change in anxiety level of subject
Description
Change in anxiety level of subject with the use of the FACES scale
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Perception of anxiety level from physician
Description
Change in perception anxiety level of subject with the use of the FACES scale
Time Frame
60 minutes
Title
Perception of pain level from physician
Description
Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale
Time Frame
60 minutes
Title
Perception of anxiety level from parent(s)
Description
Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale
Time Frame
60 minutes
Title
Perception of pain level from parent(s)
Description
Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale
Time Frame
60 minutes
Title
Meds
Description
Number of medications used to reduce anxiety in the different arms
Time Frame
4 hours
Title
Physical restrain use
Description
Number of times physical restraints are used
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huma L Siddiqui, MD
Phone
317-880-3900
Email
hksiddiq@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Pettit, MS
Phone
317-880-3900
Email
klpettit@iu.edu
Facility Information:
Facility Name
IU Health Riley Children's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassandra Hall
Phone
317-697-2850
Email
clsh@iu.edu
First Name & Middle Initial & Last Name & Degree
Kate Pettit
Phone
317-962-1190
Email
klpettit@iu.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Kline, MD
First Name & Middle Initial & Last Name & Degree
Kimberly Van Ryzin, MD
12. IPD Sharing Statement
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Canine-Assisted Anxiety Reduction In Emergency Care
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