NCT04727749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

January 22, 2021

Results QC Date

August 3, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

PainEmergency DepartmentTherapy Dog

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Anxiety Scores

    20 minutes post-visit

  • Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Depression Scores

    20 minutes post-visit

  • Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Well-Being Scores

    20 minutes post-visit

  • Change in Blood Pressure

    20 minutes post-visit

  • Change in Heart Rate

    20 minutes post-visit

Study Arms (2)

Therapy Dog Team Visit

EXPERIMENTAL

Patient interacts with the therapy dog and handler.

Behavioral: Therapy Dog Team Visit

No Therapy Dog Team Visit

NO INTERVENTION

No patient interaction with the therapy dog or handler.

Interventions

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.

Therapy Dog Team Visit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pain medications (specifically immediate release acetaminophen and opioid analgesics) within an hour prior to the visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

PainAcute PainChronic PainPain, IntractableEmergencies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Limitations and Caveats

1. Did not account for impact of handlers in therapy dog visits 2. Power analysis and larger sample needed to examine interaction of key demographic independent variables - dog experience and intersecting identity factors (ethnicity and age) 3. Intervention group of human visitation without dog not included 4. Limited to one hospital setting 5. Did not ask about medications taken at home that may have influenced pain scores 6. Various variables can influence blood pressure and heart rate

Results Point of Contact

Title
Dr. Colleen Dell
Organization
University of Saskatchewan

Study Officials

  • Colleen Dell

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Data is to be collected 5 days a week, with animal testing days alternating with control days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Chair in One Health & Wellness, Professor, Tenured

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 27, 2021

Study Start

June 7, 2019

Primary Completion

September 20, 2019

Study Completion

September 20, 2019

Last Updated

November 5, 2021

Results First Posted

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations