Pawsitive Impacts of Therapy Dog Visits
Primary Purpose
Pain, Pain, Acute, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Therapy Dog Team Visit
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Pain, Emergency Department, Therapy Dog
Eligibility Criteria
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
Sites / Locations
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapy Dog Team Visit
No Therapy Dog Team Visit
Arm Description
Patient interacts with the therapy dog and handler.
No patient interaction with the therapy dog or handler.
Outcomes
Primary Outcome Measures
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Pain Scores
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.
Change in Pain Score
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.
Secondary Outcome Measures
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Anxiety Scores
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
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Depression Scores
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
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Well-Being Scores
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.
Change in Blood Pressure
Mean arterial blood pressure using a blood pressure cuff
Change in Heart Rate
Radial pulse
Full Information
NCT ID
NCT04727749
First Posted
January 22, 2021
Last Updated
October 7, 2021
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04727749
Brief Title
Pawsitive Impacts of Therapy Dog Visits
Official Title
A Study of the Pawsitive Impacts of Therapy Dog Visits With Adult Emergency Department Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Acute, Pain, Chronic, Pain, Intractable
Keywords
Pain, Emergency Department, Therapy Dog
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Data is to be collected 5 days a week, with animal testing days alternating with control days.
Masking
Participant
Masking Description
Consent will be obtained using a deceptive consent form, which will explain that this is a pain study, but will omit any information regarding therapy dogs. Once all measures are taken, the participants will be explained the deception and asked to sign the true consent form.
Allocation
Non-Randomized
Enrollment
211 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapy Dog Team Visit
Arm Type
Experimental
Arm Description
Patient interacts with the therapy dog and handler.
Arm Title
No Therapy Dog Team Visit
Arm Type
No Intervention
Arm Description
No patient interaction with the therapy dog or handler.
Intervention Type
Behavioral
Intervention Name(s)
Therapy Dog Team Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Pain Scores
Description
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.
Time Frame
20 minutes post visit
Title
Change in Pain Score
Description
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.
Time Frame
Baseline visit compared to 20 minutes post-visit
Secondary Outcome Measure Information:
Title
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Anxiety Scores
Description
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
Time Frame
20 minutes post-visit
Title
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Depression Scores
Description
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
Time Frame
20 minutes post-visit
Title
Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Well-Being Scores
Description
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.
Time Frame
20 minutes post-visit
Title
Change in Blood Pressure
Description
Mean arterial blood pressure using a blood pressure cuff
Time Frame
20 minutes post-visit
Title
Change in Heart Rate
Description
Radial pulse
Time Frame
20 minutes post-visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Dell
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35263346
Citation
Carey B, Dell CA, Stempien J, Tupper S, Rohr B, Carr E, Cruz M, Acoose S, Butt P, Broberg L, Collard L, Fele-Slaferek L, Fornssler C, Goodridge D, Gunderson J, McKenzie H, Rubin J, Shand J, Smith J, Trask J, Ukrainetz K, Meier S. Outcomes of a controlled trial with visiting therapy dog teams on pain in adults in an emergency department. PLoS One. 2022 Mar 9;17(3):e0262599. doi: 10.1371/journal.pone.0262599. eCollection 2022.
Results Reference
derived
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Pawsitive Impacts of Therapy Dog Visits
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