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Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Primary Purpose

Anxiety Acute, Chronic Pain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Control

Dog Therapy

About this trial

This is an interventional treatment trial for Anxiety Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Eskenazi Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Morphine equivalent narcotic administration in emergency department patients with chronic pain

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

Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)

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

Change in salivary cortisol in ED patients with chronic pain

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

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

Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)

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

Change in salivary cortisol in ED patients with emotional crisis

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

Secondary Outcome Measures

Change in salivary cortisol levels in emergency department patients

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

Full Information

NCT ID

NCT04287452

First Posted

February 12, 2020

Last Updated

July 18, 2023

Sponsor

Indiana University

Collaborators

Healthcare Initiatives, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04287452

Brief Title

Canine-Assisted ANxiety Reduction IN Emergency Care IV

Acronym

CANINE IV

Official Title

Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Withdrawn

Why Stopped

The study has been withdrawn due to the pandemic and lack of funding.

Study Start Date

March 1, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

Healthcare Initiatives, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Acute, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Control

Intervention Type

Other

Intervention Name(s)

Dog Therapy

Intervention Description

Exposure to certified therapy dogs and their handler.

Primary Outcome Measure Information:

Title

Morphine equivalent narcotic administration in emergency department patients with chronic pain

Description

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

Time Frame

Date of enrollment until emergency department discharge, up to 72 hours

Title

Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)

Description

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

Time Frame

Baseline and T1 (~45 minutes after baseline)

Title

Change in salivary cortisol in ED patients with chronic pain

Description

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

Time Frame

Baseline and T1 (~45 minutes after baseline)

Title

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

Description

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

Time Frame

Date of enrollment until emergency department discharge, up to 72 hours

Title

Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)

Description

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

Time Frame

Baseline and T1 (~45 minutes after baseline)

Title

Change in salivary cortisol in ED patients with emotional crisis

Description

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

Time Frame

Baseline and T1 (~45 minutes after baseline)

Secondary Outcome Measure Information:

Title

Change in salivary cortisol levels in emergency department patients

Description

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

Time Frame

Baseline and T1 (~45 minutes after baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Eskenazi Health System

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19341990

Citation

Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.

Results Reference

background

PubMed Identifier

23170993

Citation

Marcus DA, Bernstein CD, Constantin JM, Kunkel FA, Breuer P, Hanlon RB. Impact of animal-assisted therapy for outpatients with fibromyalgia. Pain Med. 2013 Jan;14(1):43-51. doi: 10.1111/j.1526-4637.2012.01522.x. Epub 2012 Nov 21.

Results Reference

background

PubMed Identifier

9634160

Citation

Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.

Results Reference

background

PubMed Identifier

23642347

Citation

Munoz Lasa S, Maximo Bocanegra N, Valero Alcaide R, Atin Arratibel MA, Varela Donoso E, Ferriero G. Animal assisted interventions in neurorehabilitation: a review of the most recent literature. Neurologia. 2015 Jan-Feb;30(1):1-7. doi: 10.1016/j.nrl.2013.01.012. Epub 2013 May 1. English, Spanish.

Results Reference

background

Citation

Havey J, Vlasses F, Vlasses P, Ludwig P, Hackbarth D. The Effect of Animal-Assisted Therapy on Pain Medication Use After Joint Replacement. Anthrozoos 2014; 27: 361-369.

Results Reference

background

PubMed Identifier

27002161

Citation

Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.

Results Reference

background

PubMed Identifier

25315848

Citation

Kelm Z, Womer J, Walter JK, Feudtner C. Interventions to cultivate physician empathy: a systematic review. BMC Med Educ. 2014 Oct 14;14:219. doi: 10.1186/1472-6920-14-219.

Results Reference

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Canine-Assisted ANxiety Reduction IN Emergency Care IV

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