Canine-Assisted Anxiety Reduction In Emergency Care

NCT03784573 | Completed

• 1 other identifier: 1811186507
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Opioid Use; Children; Therapy Dog

Outcome Measures

Primary Outcomes (1)

• Change in anxiety level of subject

  Change in anxiety level of subject with the use of the FACES scale

  45 minutes

Secondary Outcomes (6)

• Perception of anxiety level from physician

  60 minutes

• Perception of pain level from physician

  60 minutes

• Perception of anxiety level from parent(s)

  60 minutes

• Perception of pain level from parent(s)

  60 minutes

• Meds

  4 hours

Study Arms (2)

Dog + handler

ACTIVE COMPARATOR

Behavioral: Dog + handler

No dog

PLACEBO COMPARATOR

Behavioral: No dog

Interventions

Dog + handler BEHAVIORAL

Dog + handler

Dog + handler

No dog BEHAVIORAL

No dog

No dog

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old;
• Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety

You may not qualify if:

• \- violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Kelker HP, Siddiqui HK, Beck AM, Kline JA. Therapy Dogs for Anxiety in Children in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250636. doi: 10.1001/jamanetworkopen.2025.0636.

  PMID: 40085085 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: January 7, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

US (1)