Canine-Assisted Anxiety Reduction In Emergency Care

Anxiety Clinical Trial

— CANINE III  

Official title:

Canine-Assisted Anxiety Reduction In Emergency Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03784573
• Other study ID #: 1811186507
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Children
• Emergencies
• Opioid Use
• Therapy Dog

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