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

• ClinicalTrials.gov Identifier: NCT03784573
• Recruitment Status: Unknown
• First Posted: December 24, 2018
• Last Update Posted: February 27, 2019
• Sponsor: Indiana University
• Information provided by (Responsible Party): Indiana University

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).

Condition or disease	Intervention/treatment	Phase
Anxiety; Opioid Use; Children; Therapy Dog	Behavioral: Dog + handler; Behavioral: No dog	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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)
• Primary Purpose: Supportive Care
• Official Title: Canine-Assisted Anxiety Reduction In Emergency Care
• Actual Study Start Date: January 7, 2019
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dog + handler	Behavioral: Dog + handler; Dog + handler
Placebo Comparator: No dog	Behavioral: No dog; No dog

Outcome Measures

Primary Outcome Measures :

1. Change in anxiety level of subject [ Time Frame: 45 minutes ]
   Change in anxiety level of subject with the use of the FACES scale

Secondary Outcome Measures :

1. Perception of anxiety level from physician [ Time Frame: 60 minutes ]
   Change in perception anxiety level of subject with the use of the FACES scale
2. Perception of pain level from physician [ Time Frame: 60 minutes ]
   Change in perception of pain level of subject with the use of a Wong-Baker Faces pain scale
3. Perception of anxiety level from parent(s) [ Time Frame: 60 minutes ]
   Change in perception of anxiety level of subject by their parent(s) with the use of the FACES scale
4. Perception of pain level from parent(s) [ Time Frame: 60 minutes ]
   Change in perception of pain level of subject by the parent(s) with the use of a Wong-Baker Faces pain scale
5. Meds [ Time Frame: 4 hours ]
   Number of medications used to reduce anxiety in the different arms
6. Physical restrain use [ Time Frame: 4 hours ]
   Number of times physical restraints are used

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Cassandra L Hall; 317-697-2850; clsh@iu.edu

Contact: Kate Pettit; 317-962-1190; klpettit@iu.edu

Locations

United States, Indiana

IU Health Riley Children's Hospital; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Cassandra Hall 317-697-2850 clsh@iu.edu

Contact: Kate Pettit 317-962-1190 klpettit@iu.edu

Principal Investigator: Jeffrey Kline, MD

Sub-Investigator: Kimberly Van Ryzin, MD

Sponsors and Collaborators

Indiana University

More Information

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT03784573
• Other Study ID Numbers: 1811186507
• First Posted: December 24, 2018
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Emergencies; Anxiety Disorders; Mental Disorders; Disease Attributes; Pathologic Processes