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| Name | Class |
|---|---|
| Royal University Hospital Foundation | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Dog Team Visit | Experimental | Patient interacts with the therapy dog and handler. |
|
| No Therapy Dog Team Visit | No Intervention | No patient interaction with the therapy dog or handler. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapy Dog Team Visit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline visit compared to 20 minutes post-visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20 minutes post-visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Dell | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35263346 | Derived | 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. |
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Recruitment took place at the Emergency Department of the Royal University Hospital in Saskatoon, SK, between June and September of 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy Dog Team Visit | Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: 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. |
| FG001 | No Therapy Dog Team Visit | No patient interaction with the therapy dog or handler. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy Dog Team Visit | Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 20 minutes post visit |
|
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Death, serious adverse effects, and other (non-serious adverse effects) were not assessed for this study. An intervention of interaction with a therapy dog is not expected to put participants at risk of Serious Adverse Events, All-Cause Mortality, or Other.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapy Dog Team Visit | Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colleen Dell | University of Saskatchewan | 306-966-5912 | Colleen.Dell@usask.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2019 | Jun 23, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D010148 | Pain, Intractable |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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Data is to be collected 5 days a week, with animal testing days alternating with control days.
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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.
| 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 | 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. | 20 minutes post-visit |
| Change in Blood Pressure | Mean arterial blood pressure using a blood pressure cuff | 20 minutes post-visit |
| Change in Heart Rate | Radial pulse | 20 minutes post-visit |
| No Therapy Dog Team Visit |
No patient interaction with the therapy dog or handler. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pain Score (ESAS-r) A higher number represents a worse outcome | Count of Participants | Participants |
|
| Anxiety Score (ESAS-r) A higher number represents a worse outcome | Count of Participants | Participants |
|
| Depression Score (ESAS-r) A higher number represents a worse outcome | Count of Participants | Participants |
|
| Well-being Score (ESAS-r) A higher number represents a worse outcome | Count of Participants | Participants |
|
| Blood Pressure | Median | Full Range | mm HG |
|
| Heart Rate | Median | Full Range | bpm |
|
No patient interaction with the therapy dog or handler. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit compared to 20 minutes post-visit |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 20 minutes post-visit |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 20 minutes post-visit |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 20 minutes post-visit |
|
|
|
| Secondary | Change in Blood Pressure | Mean arterial blood pressure using a blood pressure cuff | Posted | Mean | Standard Deviation | mm HG | 20 minutes post-visit |
|
|
|
| Secondary | Change in Heart Rate | Radial pulse | Posted | Mean | Standard Deviation | BPM | 20 minutes post-visit |
|
|
|
| Post-Hoc | Change in Anxiety Score | Anxiety score is measured 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit compared to 20 minutes post-visit |
|
|
|
| Post-Hoc | Change in Depression Score | Depression 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit compared to 20 minutes post-visit |
|
|
|
| Post-Hoc | Change in Well-Being Score | Well-Being 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline visit compared to 20 minutes post-visit |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Therapy Dog Team Visit | No patient interaction with the therapy dog or handler. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D010335 | Pathologic Processes |
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