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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03784573
Other study ID # 1811186507
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date July 31, 2024

Study information

Verified date May 2023
Source Indiana University
Contact Huma L Siddiqui, MD
Phone 317-880-3900
Email hksiddiq@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 17 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Dog + handler
Dog + handler
No dog
No dog

Locations

Country Name City State
United States IU Health Riley Children's Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in anxiety level of subject Change in anxiety level of subject with the use of the FACES scale 45 minutes
Secondary Perception of anxiety level from physician Change in perception anxiety level of subject with the use of the FACES scale 60 minutes
Secondary 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
Secondary 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
Secondary 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
Secondary Meds Number of medications used to reduce anxiety in the different arms 4 hours
Secondary Physical restrain use Number of times physical restraints are used 4 hours
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