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

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

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)

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dog + handler Behavioral: Dog + handler
Dog + handler

Placebo Comparator: No dog Behavioral: No dog
No dog




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



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784573


Contacts
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Contact: Cassandra L Hall 317-697-2850 clsh@iu.edu
Contact: Kate Pettit 317-962-1190 klpettit@iu.edu

Locations
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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

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Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT03784573     History of Changes
Other Study ID Numbers: 1811186507
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Anxiety Disorders
Mental Disorders
Disease Attributes
Pathologic Processes