Canine-Assisted Anxiety Reduction In Emergency Care (CANINE III)

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).

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Children; Opioid Use; Therapy Dog
• Intervention / Treatment: Behavioral: Dog + handler; Behavioral: No dog

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)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huma L Siddiqui, MD; Phone Number: 317-880-3900; Email: hksiddiq@iu.edu
• Study Contact Backup: Name: Kate Pettit, MS; Phone Number: 317-880-3900; Email: klpettit@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Riley Children's Hospital
      • Contact: Kate Pettit; Phone Number: 317-962-1190; Email: klpettit@iu.edu
      • Contact: Cassandra Hall; Phone Number: 317-697-2850; Email: clsh@iu.edu
      • Principal Investigator: Jeffrey Kline, MD
      • Sub-Investigator: Kimberly Van Ryzin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dog + handler	Behavioral: Dog + handler; Dog + handler
Placebo Comparator: No dog	Behavioral: No dog; No dog

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Emergencies; Anxiety Disorders
• Other Study ID Numbers: 1811186507

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No