- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471429
Canine-assisted ANxiety Reduction IN Emergency (CANINE)
September 20, 2018 updated by: Indiana University
The purpose of this study is to see if dogs can reduce the anxiety level of patients in the emergency department.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients will score their pain, anxiety, and depression.
A dog will then come into the patient's room for approximately 15 minutes after which the patient will score his/her pain, anxiety, and depression again.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients enrolled from Emergency Department that are 18 or older with moderate or greater anxiety, per physician Gestalt.
Description
Inclusion Criteria:
- Research staff will screen for inclusion criterion by asking the care providers if they agree with this statement, "I believe this patient is experiencing moderate or greater anxiety".
Exclusion Criteria:
- Extreme intoxication, agitation that precludes conversation with the patient, fear of dogs, dog bite, allergy to dogs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Dog
Patient sees therapy dog for 15 minutes, which is standard of care at this hospital.
|
No Dog
Patient receives standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety reduction from Scale
Time Frame: 30 mins
|
reduction in anxiety score (0-10).
0=balanced mood (least anxiety) 2= slight fear and worry 4=mild fear and worry 6= moderate worry, physical agitation 8=Feeling really bad, at the edge 10=out of control behavior, self-harm (worst anxiety)
|
30 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain reduction from Wong Baker faces scale
Time Frame: 30 mins
|
reduction in pain score (0-10).
0=no hurt (least pain) 2= Hurts little bit 4= Hurts little more 6= Hurts even more 8= Hurts whole lot 10=out of control behavior, self-harm (hurts worst)
|
30 mins
|
Depression reduction from scale
Time Frame: 30 mins
|
reduction in depression score (0-10).
0= Balanced mood (least depressed) 2= Slightly depressed 4= Mildly depressed 6= Definite malaise 8= Feeling reall bad, at the edge 10=Despair, suicidal feelings (worst depressed)
|
30 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2017
Primary Completion (Actual)
April 4, 2018
Study Completion (Actual)
April 4, 2018
Study Registration Dates
First Submitted
February 20, 2018
First Submitted That Met QC Criteria
March 13, 2018
First Posted (Actual)
March 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2018
Last Update Submitted That Met QC Criteria
September 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CANINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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