Canine Assisted Therapy to Reduce Emergency Care Provider Stress (CANINE II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03628820|
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress Anxiety||Behavioral: Dog Therapy Behavioral: Coloring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Canine Assisted Therapy to Reduce Emergency Care Provider Stress|
|Actual Study Start Date :||May 17, 2018|
|Actual Primary Completion Date :||August 9, 2019|
|Actual Study Completion Date :||August 9, 2019|
Experimental: Therapy Dog
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
5 minutes spent with therapy dog during shift
Experimental: Mandala Coloring
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.
5 minutes spend coloring mandalas during shift
No Intervention: No Intervention
This group is not exposed to the therapy dog or handler.
- Cortisol change [ Time Frame: 4 hours ]
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
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): NCT03628820
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|