NCT03628820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

July 18, 2018

Last Update Submit

February 12, 2020

Conditions

Keywords

StressAnxietyCortisolTherapyDogColoringMandala

Outcome Measures

Primary Outcomes (1)

  • 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

    4 hours

Study Arms (3)

Therapy Dog

EXPERIMENTAL

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.

Behavioral: Dog Therapy

Mandala Coloring

EXPERIMENTAL

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.

Behavioral: Coloring

No Intervention

NO INTERVENTION

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

Interventions

Dog TherapyBEHAVIORAL

5 minutes spent with therapy dog during shift

Therapy Dog
ColoringBEHAVIORAL

5 minutes spend coloring mandalas during shift

Mandala Coloring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will include residents, faculty and nurses who work in the emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emergency Medicine

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 14, 2018

Study Start

May 17, 2018

Primary Completion

August 9, 2019

Study Completion

August 9, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations