search
Back to results

Canine Assisted Therapy to Reduce Emergency Care Provider Stress (CANINE II)

Primary Purpose

Stress, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dog Therapy
Coloring
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress focused on measuring Stress, Anxiety, Cortisol, Therapy, Dog, Coloring, Mandala

Eligibility Criteria

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

Inclusion Criteria:

  • Inclusion criteria require that participants work full time as either a nurse or physician in the Eskenazi emergency department and are willing to consent to participation.
  • Participants will include residents, faculty and nurses who work in the emergency department

Exclusion Criteria:

  • Exclusions include any reported prior fear or adverse reaction to dogs

Sites / Locations

  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Therapy Dog

Mandala Coloring

No Intervention

Arm Description

This group is exposed to the therapy dog and handler. On a convenience sample of shifts, a dog will be available. Participants will not know when dogs will be present and will not be informed of whether or not they will see a dog on any given shift. The dog and handler will be kept out of site of other providers. Participants who agree to participate will be approached by study personnel between 3 and 7 hours into his or her shift and asked "would now be a good time to see a therapy dog?" If the physician answers yes, then the physician will be escorted to a separate private, quiet room away from the usual work area to interact with a therapy dog and handler. We will ask the physician to spend approximately 5 minutes with the therapy dog, but will not specify or mandate any time. Study personnel will record the time spent. Only the handler and dog will be present in the room.

This group is not exposed to the therapy dog or handler. At 3-7 hours into the shift, study personnel will encourage providers to take a 5 min period of mindfulness, achieved by coloring mandalas. Participants will be escorted out of the work area to the same private, quiet room where the interaction occurs with the dog and handler in the therapy dog group. Participants will have their choice of one of three mandalas to color and will be provided a full palette of colored pencils. When the provider's time is up, study personnel will notify them of the five minute period. Study personnel will not be present in the room but will photograph the work when the participant is done with the session and record the image in REDcap. The original art work will be returned to the provider.

This group is not exposed to the therapy dog or handler.

Outcomes

Primary Outcome Measures

Cortisol change
Time and location of shift and times of each measurement. T1: As soon as practicable at shift start: Baseline perceived stress scale and anxiety scale (shown below) and approximately 100 uL of saliva using a commercial kit (Salimetrics® 1-3002 (5PK 1-3002-5)). Saliva is collected > 10 min after any eating or drinking. T2: Repeat perceived stress scale, anxiety scale and saliva approximately 15-30 min after exposure to the dog and handler or the coloring. Scale 0 to 10 0=balanced mood 2=slight fear and worry 4= mild fear and worry 6=moderate worry, physical agitation 8= strong agitation, pacing, can't sit still 10= out of control behavior, self-harm

Secondary Outcome Measures

Full Information

First Posted
July 18, 2018
Last Updated
February 12, 2020
Sponsor
Indiana University
search

1. Study Identification

Unique Protocol Identification Number
NCT03628820
Brief Title
Canine Assisted Therapy to Reduce Emergency Care Provider Stress
Acronym
CANINE II
Official Title
Canine Assisted Therapy to Reduce Emergency Care Provider Stress
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main study hypothesis is that emergency healthcare workers on shift who interact for 5 min with a therapy dog and handler will have lower perceived and manifested stress response compared with use of a time out that includes voluntary use of a coloring mandalas. The work will also address two exploratory hypotheses: The first is that salivary cortisol will correlate significantly with perceived stress and will increase from beginning to end of shift, and that exposure to a therapy dog will blunt this increase. The second exploratory hypothesis states that participants who interact with a therapy dog will display more empathic behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety
Keywords
Stress, Anxiety, Cortisol, Therapy, Dog, Coloring, Mandala

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy Dog
Arm Type
Experimental
Arm Description
This group is exposed to the therapy dog and handler. On a convenience sample of shifts, a dog will be available. Participants will not know when dogs will be present and will not be informed of whether or not they will see a dog on any given shift. The dog and handler will be kept out of site of other providers. Participants who agree to participate will be approached by study personnel between 3 and 7 hours into his or her shift and asked "would now be a good time to see a therapy dog?" If the physician answers yes, then the physician will be escorted to a separate private, quiet room away from the usual work area to interact with a therapy dog and handler. We will ask the physician to spend approximately 5 minutes with the therapy dog, but will not specify or mandate any time. Study personnel will record the time spent. Only the handler and dog will be present in the room.
Arm Title
Mandala Coloring
Arm Type
Experimental
Arm Description
This group is not exposed to the therapy dog or handler. At 3-7 hours into the shift, study personnel will encourage providers to take a 5 min period of mindfulness, achieved by coloring mandalas. Participants will be escorted out of the work area to the same private, quiet room where the interaction occurs with the dog and handler in the therapy dog group. Participants will have their choice of one of three mandalas to color and will be provided a full palette of colored pencils. When the provider's time is up, study personnel will notify them of the five minute period. Study personnel will not be present in the room but will photograph the work when the participant is done with the session and record the image in REDcap. The original art work will be returned to the provider.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
This group is not exposed to the therapy dog or handler.
Intervention Type
Behavioral
Intervention Name(s)
Dog Therapy
Intervention Description
5 minutes spent with therapy dog during shift
Intervention Type
Behavioral
Intervention Name(s)
Coloring
Intervention Description
5 minutes spend coloring mandalas during shift
Primary Outcome Measure Information:
Title
Cortisol change
Description
Time and location of shift and times of each measurement. T1: As soon as practicable at shift start: Baseline perceived stress scale and anxiety scale (shown below) and approximately 100 uL of saliva using a commercial kit (Salimetrics® 1-3002 (5PK 1-3002-5)). Saliva is collected > 10 min after any eating or drinking. T2: Repeat perceived stress scale, anxiety scale and saliva approximately 15-30 min after exposure to the dog and handler or the coloring. Scale 0 to 10 0=balanced mood 2=slight fear and worry 4= mild fear and worry 6=moderate worry, physical agitation 8= strong agitation, pacing, can't sit still 10= out of control behavior, self-harm
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria require that participants work full time as either a nurse or physician in the Eskenazi emergency department and are willing to consent to participation. Participants will include residents, faculty and nurses who work in the emergency department Exclusion Criteria: Exclusions include any reported prior fear or adverse reaction to dogs
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Canine Assisted Therapy to Reduce Emergency Care Provider Stress

We'll reach out to this number within 24 hrs