CompletedNCT04727749Updated Nov 5, 2021Results posted

Pawsitive Impacts of Therapy Dog Visits

An interventional study of Therapy Dog Team Visit in Pain, Pain, Acute and Pain, Chronic, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-05.

Sponsored by University of Saskatchewan · Not applicable, Interventional, and Supportive care

From the registry’s dates

Registered 1 year 7 months after the study started (first participant enrolled Jun 2019, registered Jan 2021).

Phase: Not applicable
Study type: Interventional
Enrollment: 211
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Pain
Pain, Acute
Pain, Chronic
Pain, Intractable

Browse trials for

Keywords

Pain
Emergency Department
Therapy Dog

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 211 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.

Browse University of Saskatchewan studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 211 participants (actual)

Study arms

Experimental
Therapy Dog Team Visit
Patient interacts with the therapy dog and handler.
Behavioral: Therapy Dog Team Visit
No intervention
No Therapy Dog Team Visit
No patient interaction with the therapy dog or handler.

Interventions

BehavioralTherapy 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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Baseline visit compared to 20 minutes post-visit

Secondary outcomes

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
Time frame: 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
Time frame: 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.
Time frame: 20 minutes post-visit
Change in Blood Pressure
Mean arterial blood pressure using a blood pressure cuff
Time frame: 20 minutes post-visit
Change in Heart Rate
Radial pulse
Time frame: 20 minutes post-visit

Results

Posted Nov 5, 2021

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

Participant flow

Recruitment took place at the Emergency Department of the Royal University Hospital in Saskatoon, SK, between June and September of 2019.

Participant flow — Overall Study
Milestone	Therapy Dog Team Visit	No Therapy Dog Team Visit
Started	107	104
Completed	97	101
Not completed	10	3
Withdrew: Lost to follow-up	10	3

Outcome measures

PrimaryNumber 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.

Time frame:: 20 minutes post visit
Reported as:: Count of participants · Participants

Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Pain Scores
Participants	Therapy Dog Team Visit	No Therapy Dog Team Visit
0	50	43
1	7	7
2	3	13
3	5	3
4	7	11
5	7	7
6	4	4
7	9	4
8	4	3
9	0	6
10	1	0

PrimaryChange 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.

Time frame:: Baseline visit compared to 20 minutes post-visit
Reported as:: Mean · units on a scale

Change in Pain Score
units on a scale	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Pain Score	-0.90 ± 2.05	0.03 ± 2.30

SecondaryNumber 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

Time frame:: 20 minutes post-visit
Reported as:: Count of participants · Participants

Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Anxiety Scores
Participants	Therapy Dog Team Visit	No Therapy Dog Team Visit
0	55	45
1	3	7
2	6	13
3	11	8
4	4	6
5	8	9
6	1	3
7	5	2
8	3	4
9	0	0
10	1	5

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

Time frame:: 20 minutes post-visit
Reported as:: Count of participants · Participants

Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Depression Scores
Participants	Therapy Dog Team Visit	No Therapy Dog Team Visit
0	51	55
1	5	7
2	5	7
3	7	7
4	7	5
5	4	5
6	6	1
7	0	2
8	4	6
9	0	3
10	1	2

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

Time frame:: 20 minutes post-visit
Reported as:: Count of participants · Participants

Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Well-Being Scores
Participants	Therapy Dog Team Visit	No Therapy Dog Team Visit
0	14	15
1	5	6
2	8	8
3	12	12
4	12	11
5	26	26
6	6	7
7	7	7
8	5	5
9	2	2
10	0	0

SecondaryChange in Blood Pressure

Mean arterial blood pressure using a blood pressure cuff

Time frame:: 20 minutes post-visit
Reported as:: Mean · mm HG

Change in Blood Pressure
mm HG	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Blood Pressure	1.01 ± 10.7	-.04 ± 8.07

SecondaryChange in Heart Rate

Radial pulse

Time frame:: 20 minutes post-visit
Reported as:: Mean · BPM

Change in Heart Rate
BPM	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Heart Rate	.48 ± 11.68	-.4 ± 8.02

Post-hocChange 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.

Time frame:: Baseline visit compared to 20 minutes post-visit
Reported as:: Mean · units on a scale

Change in Anxiety Score
units on a scale	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Anxiety Score	-1.13 ± 2.46	-0.11 ± 2.60

Post-hocChange 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.

Time frame:: Baseline visit compared to 20 minutes post-visit
Reported as:: Mean · units on a scale

Change in Depression Score
units on a scale	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Depression Score	-0.72 ± 1.71	0.02 ± 1.77

Post-hocChange 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.

Time frame:: Baseline visit compared to 20 minutes post-visit
Reported as:: Mean · units on a scale

Change in Well-Being Score
units on a scale	Therapy Dog Team Visit	No Therapy Dog Team Visit
Change in Well-Being Score	-0.87 ± 1.84	0.14 ± 1.84

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Therapy Dog Team Visit	—	—	—
No Therapy Dog Team Visit	—	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
Median	60 (18 to 96)	63 (18 to 95)	62 (18 to 96)

Sex: Female, Male
Sex: Female, Male(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
Female	47	47	94
Male	60	57	117

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
Ethnic Origin — Aboriginal Peoples of North America	9	16	25
Ethnic Origin — Black	2	1	3
Ethnic Origin — Filipino	1	3	4
Ethnic Origin — South Asian	0	1	1
Ethnic Origin — White	95	81	176
Ethnic Origin — White, Aboriginal Peoples of North America	0	2	2

Region of Enrollment
Region of Enrollment(participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
Canada	109	102	211

Pain Score (ESAS-r) A higher number represents a worse outcome
Pain Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	43	43	86
1	6	7	13
2	9	11	20
3	7	8	15
4	4	9	13
5	7	8	15
6	11	5	16
7	5	6	11
8	6	3	9
9	3	3	6
10	6	1	7

Anxiety Score (ESAS-r) A higher number represents a worse outcome
Anxiety Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	36	43	79
1	9	11	20
2	7	12	19
3	6	9	15
4	11	2	13
5	9	11	20
6	11	4	15
7	7	3	10
8	7	2	9
9	0	0	0
10	4	7	11

Depression Score (ESAS-r) A higher number represents a worse outcome
Depression Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	52	59	111
1	4	6	10
2	9	8	17
3	13	3	16
4	5	2	7
5	3	9	12
6	7	4	11
7	2	2	4
8	6	4	10
9	1	5	6
10	5	2	7

Well-being Score (ESAS-r) A higher number represents a worse outcome
Well-being Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	6	13	19
1	5	6	11
2	7	16	23
3	18	8	26
4	11	12	23
5	17	25	42
6	13	7	20
7	16	8	24
8	6	3	9
9	2	3	5
10	5	3	8

2 further baseline measures are reported on the registry.

Study locations

1 site

Royal University Hospital
Saskatoon, Saskatchewan S7N 0W8, Canada

References and documents

Publications

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. PubMed 35263346 ↗

Study documents

Study protocol ↗ · Apr 22, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2019 to primary completion in Sep 2019, 3 months.

Results were first posted in Nov 2021, 2 years 1 month after primary completion.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 3 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 22, 2021
First posted: Jan 27, 2021
StartActual: Jun 7, 2019
Primary completionActual: Sep 20, 2019
CompletionActual: Sep 20, 2019
Results first posted: Nov 5, 2021
Last update: Nov 5, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04727749
Lead sponsor: University of Saskatchewan
Collaborators: Royal University Hospital Foundation
Responsible party: Colleen Dell (Research Chair in One Health & Wellness, Professor, Tenured, University of Saskatchewan) — Principal investigator
First posted: Jan 27, 2021
Start date: Jun 7, 2019
Primary completion: Sep 20, 2019
Completion: Sep 20, 2019
Results posted: Nov 5, 2021
Last update: Nov 5, 2021

Study contacts

Colleen Dell

principal investigator · University of Saskatchewan

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Anxiety Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	36	43	79
1	9	11	20
2	7	12	19
3	6	9	15
4	11	2	13
5	9	11	20
6	11	4	15
7	7	3	10
8	7	2	9
9	0	0	0
10	4	7	11

Well-being Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	6	13	19
1	5	6	11
2	7	16	23
3	18	8	26
4	11	12	23
5	17	25	42
6	13	7	20
7	16	8	24
8	6	3	9
9	2	3	5
10	5	3	8

Anxiety Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	36	43	79
1	9	11	20
2	7	12	19
3	6	9	15
4	11	2	13
5	9	11	20
6	11	4	15
7	7	3	10
8	7	2	9
9	0	0	0
10	4	7	11

Well-being Score (ESAS-r) A higher number represents a worse outcome(Participants)	Therapy Dog Team Visit	No Therapy Dog Team Visit	Total
0	6	13	19
1	5	6	11
2	7	16	23
3	18	8	26
4	11	12	23
5	17	25	42
6	13	7	20
7	16	8	24
8	6	3	9
9	2	3	5
10	5	3	8