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OpenTrials
Completed

NCT Number: NCT03784573

Canine-Assisted Anxiety Reduction In Emergency Care

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).

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dog + handler

Behavioral

Dog + handler

No dog

Behavioral

No dog

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: CANINE III

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2018
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.