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CANINE IV: Canine-Assisted ANxiety Reduction IN Emergency Care IV

Sponsor
Jeffrey Kline (Other)
Overall Status
Unknown status
CT.gov ID
NCT04287452
Collaborator
Healthcare Initiatives, Inc. (Other)
300
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
33.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;

  • decrease reported anxiety levels in emergency department (ED) patients,

  • decrease salivary cortisol in ED patients,

  • decrease total morphine equivalent dosing in the emergency department or at discharge and/or,

  • decrease reported stress levels in emergency department providers caring for participating patients

when compared to usual care.

Condition or Disease Intervention/Treatment Phase
  • Other: Control
  • Other: Dog Therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Emergency department patients enrolled in the control arm will receive usual care. Emergency department providers enrolled in the control arm will work their shift as usual.

Other: Control
Control
Active Comparator: Intervention

Emergency department patients and providers in the intervention arm will be exposed to and/or interact with a certified therapy dog and handler

Other: Dog Therapy
Exposure to certified therapy dogs and their handler.

Outcome Measures

Primary Outcome Measures

  1. Morphine equivalent narcotic administration in emergency department patients with chronic pain [Date of enrollment until emergency department discharge, up to 72 hours]

    Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.

  2. Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst) [Baseline and T1 (~45 minutes after baseline)]

    Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1

  3. Change in salivary cortisol in ED patients with chronic pain [Baseline and T1 (~45 minutes after baseline)]

    Change in salivary cortisol levels in emergency department patients between baseline and T1

  4. Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis [Date of enrollment until emergency department discharge, up to 72 hours]

    Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis

  5. Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst) [Baseline and T1 (~45 minutes after baseline)]

    Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1

  6. Change in salivary cortisol in ED patients with emotional crisis [Baseline and T1 (~45 minutes after baseline)]

    Change in salivary cortisol levels in emergency department patients between baseline and T1

Secondary Outcome Measures

  1. Change in salivary cortisol levels in emergency department patients [Baseline and T1 (~45 minutes after baseline)]

    Change in salivary cortisol levels in emergency department patients between baseline and T1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients

  • Age 18-89 years

  • Chronic pain, defined as pain on most days for >6 weeks

  • Triage pain score >6 out of 10

OR

  • Age 18-89 years

  • Currently experience crisis, including suicidality, or

  • Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale

Providers

• Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.

Therapy Dog Handlers

• Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program

Exclusion Criteria:

Patients

  • Violent behavior

  • Overt intoxication

  • Non-English speaking

  • Any reported prior fear or adverse reaction to dogs

Providers

• Any reported prior fear or adverse reaction to dogs

Therapy Dog Handlers

• None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eskenazi Health System Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Jeffrey Kline
  • Healthcare Initiatives, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jeffrey Kline, Vice Chair of Research, Indiana University
ClinicalTrials.gov Identifier:
NCT04287452
Other Study ID Numbers:
  • 001968358
First Posted:
Feb 27, 2020
Last Update Posted:
Feb 27, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Emergencies
Chronic Pain
Anxiety Disorders

Study Results

No Results Posted as of Feb 27, 2020