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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03628820
Other study ID # 1804891471
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 17, 2018
Est. completion date August 9, 2019

Study information

Verified date February 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date August 9, 2019
Est. primary completion date August 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dog Therapy
5 minutes spent with therapy dog during shift
Coloring
5 minutes spend coloring mandalas during shift

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (SalimetricsĀ® 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
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