- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727749
Pawsitive Impacts of Therapy Dog Visits
A Study of the Pawsitive Impacts of Therapy Dog Visits With Adult Emergency Department Pain Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this unique 18 month study is to better understand the experiences of pain patients in the Royal University Hospital (RUH) Emergency Department (ED), to create excellence in health care. The purpose is to measure the impact of visiting therapy dogs on reducing ED patient pain.
The background rationale is that pain is the primary reason individuals attend an ED, patient pain is generally not well managed in EDs, Saskatchewan EDs have among the longest wait times in the country, and anxiety associated with ED waiting can negatively impact patients' pain.
Research suggests a therapy dog can change patients' perceptions of pain and its intensity and facilitate relaxation. The intervention will be examined for its impact on patients' sensory pain (i.e., physical pain severity), affective pain (i.e., emotional pain unpleasantness) and anxiety.
It is important to find creative, low-cost ways to respond to patients attending the ED for pain. The primary objective of this study is to generate new health-related knowledge on the ED pain patient experience. The secondary objectives are to implement effective end-of-grant knowledge translation and dissemination strategies and undertake a successful model of collaborative, multidisciplinary research among researchers, patient advisors and system representatives, rooted in a One Health framework.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over the age of 18
- Able to provide consent
- Attending the Emergency Department because of pain/discomfort
- Canadian Triage and Acuity Score (CTAS) of 2-5
- Willing to visit with a therapy dog team (intervention group only)
Exclusion Criteria:
- Pain medications (specifically immediate release acetaminophen and opioid analgesics) within an hour prior to the visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapy Dog Team Visit
Patient interacts with the therapy dog and handler.
|
For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit.
|
No Intervention: No Therapy Dog Team Visit
No patient interaction with the therapy dog or handler.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Pain Scores
Time Frame: 20 minutes post visit
|
Participants Stratified by Pain scores Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scale (scale of 0 to 10), in which higher ratings indicate worse outcomes, Pain Scores at 20 Minutes Post Visit.
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20 minutes post visit
|
Change in Pain Score
Time Frame: Baseline visit compared to 20 minutes post-visit
|
Pain score using the Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scale (scale of 0 to 10), in which higher ratings indicate worse outcomes.
|
Baseline visit compared to 20 minutes post-visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Anxiety Scores
Time Frame: 20 minutes post-visit
|
Participants Stratified by Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scale (scale of 0 to 10), in which higher ratings indicate worse outcomes, Anxiety Scores at 20 Minutes Post Visit
|
20 minutes post-visit
|
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Depression Scores
Time Frame: 20 minutes post-visit
|
Participants Stratified by Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scale (scale of 0 to 10), in which higher ratings indicate worse outcomes, Depression Scores at 20 Minutes Post Visit
|
20 minutes post-visit
|
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Well-Being Scores
Time Frame: 20 minutes post-visit
|
Participants Stratified by Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scale (scale of 0 to 10), in which higher ratings indicate worse outcomes, Well-being Scores at 20 Minutes Post Visit.
|
20 minutes post-visit
|
Change in Blood Pressure
Time Frame: 20 minutes post-visit
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Mean arterial blood pressure using a blood pressure cuff
|
20 minutes post-visit
|
Change in Heart Rate
Time Frame: 20 minutes post-visit
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Radial pulse
|
20 minutes post-visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Colleen Dell, University of Saskatchewan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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