Pawsitive Impacts of Therapy Dog Visits

Sponsor
University of Saskatchewan (Other)
Overall Status
Completed
CT.gov ID
NCT04727749
Collaborator
Royal University Hospital Foundation (Other)
211
1
2
3.4
61.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapy Dog Team Visit
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Data is to be collected 5 days a week, with animal testing days alternating with control days.Data is to be collected 5 days a week, with animal testing days alternating with control days.
Masking:
Single (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.
Primary Purpose:
Supportive Care
Official Title:
A Study of the Pawsitive Impacts of Therapy Dog Visits With Adult Emergency Department Pain Patients
Actual Study Start Date :
Jun 7, 2019
Actual Primary Completion Date :
Sep 20, 2019
Actual Study Completion Date :
Sep 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Therapy Dog Team Visit

Patient interacts with the therapy dog and handler.

Behavioral: 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.

No Intervention: No Therapy Dog Team Visit

No patient interaction with the therapy dog or handler.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Stratified by Edmonton Symptom Assessment System (Revised Version) (ESAS-r) Pain Scores [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.

  2. Change in Pain Score [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.

Secondary Outcome Measures

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

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

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

  4. Change in Blood Pressure [20 minutes post-visit]

    Mean arterial blood pressure using a blood pressure cuff

  5. Change in Heart Rate [20 minutes post-visit]

    Radial pulse

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal University Hospital Saskatoon Saskatchewan Canada S7N 0W8

Sponsors and Collaborators

  • University of Saskatchewan
  • Royal University Hospital Foundation

Investigators

  • Principal Investigator: Colleen Dell, University of Saskatchewan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Colleen Dell, Research Chair in One Health & Wellness, Professor, Tenured, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT04727749
Other Study ID Numbers:
  • 1253
First Posted:
Jan 27, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Colleen Dell, Research Chair in One Health & Wellness, Professor, Tenured, University of Saskatchewan
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Recruitment took place at the Emergency Department of the Royal University Hospital in Saskatoon, SK, between June and September of 2019.
Pre-assignment Detail
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
Period Title: Overall Study
STARTED 107 104
COMPLETED 97 101
NOT COMPLETED 10 3

Baseline Characteristics

Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit Total
Arm/Group Description 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. No patient interaction with the therapy dog or handler. Total of all reporting groups
Overall Participants 107 104 211
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
60
63
62
Sex: Female, Male (Count of Participants)
Female
47
43.9%
47
45.2%
94
44.5%
Male
60
56.1%
57
54.8%
117
55.5%
Race/Ethnicity, Customized (Count of Participants)
Aboriginal Peoples of North America
9
8.4%
16
15.4%
25
11.8%
Black
2
1.9%
1
1%
3
1.4%
Filipino
1
0.9%
3
2.9%
4
1.9%
South Asian
0
0%
1
1%
1
0.5%
White
95
88.8%
81
77.9%
176
83.4%
White, Aboriginal Peoples of North America
0
0%
2
1.9%
2
0.9%
Region of Enrollment (participants) [Number]
Canada
109
101.9%
102
98.1%
211
100%
Pain Score (ESAS-r) A higher number represents a worse outcome (Count of Participants)
0
43
40.2%
43
41.3%
86
40.8%
1
6
5.6%
7
6.7%
13
6.2%
2
9
8.4%
11
10.6%
20
9.5%
3
7
6.5%
8
7.7%
15
7.1%
4
4
3.7%
9
8.7%
13
6.2%
5
7
6.5%
8
7.7%
15
7.1%
6
11
10.3%
5
4.8%
16
7.6%
7
5
4.7%
6
5.8%
11
5.2%
8
6
5.6%
3
2.9%
9
4.3%
9
3
2.8%
3
2.9%
6
2.8%
10
6
5.6%
1
1%
7
3.3%
Anxiety Score (ESAS-r) A higher number represents a worse outcome (Count of Participants)
0
36
33.6%
43
41.3%
79
37.4%
1
9
8.4%
11
10.6%
20
9.5%
2
7
6.5%
12
11.5%
19
9%
3
6
5.6%
9
8.7%
15
7.1%
4
11
10.3%
2
1.9%
13
6.2%
5
9
8.4%
11
10.6%
20
9.5%
6
11
10.3%
4
3.8%
15
7.1%
7
7
6.5%
3
2.9%
10
4.7%
8
7
6.5%
2
1.9%
9
4.3%
9
0
0%
0
0%
0
0%
10
4
3.7%
7
6.7%
11
5.2%
Depression Score (ESAS-r) A higher number represents a worse outcome (Count of Participants)
0
52
48.6%
59
56.7%
111
52.6%
1
4
3.7%
6
5.8%
10
4.7%
2
9
8.4%
8
7.7%
17
8.1%
3
13
12.1%
3
2.9%
16
7.6%
4
5
4.7%
2
1.9%
7
3.3%
5
3
2.8%
9
8.7%
12
5.7%
6
7
6.5%
4
3.8%
11
5.2%
7
2
1.9%
2
1.9%
4
1.9%
8
6
5.6%
4
3.8%
10
4.7%
9
1
0.9%
5
4.8%
6
2.8%
10
5
4.7%
2
1.9%
7
3.3%
Well-being Score (ESAS-r) A higher number represents a worse outcome (Count of Participants)
0
6
5.6%
13
12.5%
19
9%
1
5
4.7%
6
5.8%
11
5.2%
2
7
6.5%
16
15.4%
23
10.9%
3
18
16.8%
8
7.7%
26
12.3%
4
11
10.3%
12
11.5%
23
10.9%
5
17
15.9%
25
24%
42
19.9%
6
13
12.1%
7
6.7%
20
9.5%
7
16
15%
8
7.7%
24
11.4%
8
6
5.6%
3
2.9%
9
4.3%
9
2
1.9%
3
2.9%
5
2.4%
10
5
4.7%
3
2.9%
8
3.8%
Blood Pressure (mm HG) [Median (Full Range) ]
Systolic
126
129
127
Diastolic
74
73
73
Heart Rate (bpm) [Median (Full Range) ]
Median (Full Range) [bpm]
77
77
77

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
0
50
46.7%
43
41.3%
1
7
6.5%
7
6.7%
2
3
2.8%
13
12.5%
3
5
4.7%
3
2.9%
4
7
6.5%
11
10.6%
5
7
6.5%
7
6.7%
6
4
3.7%
4
3.8%
7
9
8.4%
4
3.8%
8
4
3.7%
3
2.9%
9
0
0%
6
5.8%
10
1
0.9%
0
0%
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [units on a scale]
-0.90
(2.05)
0.03
(2.30)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
0
55
51.4%
45
43.3%
1
3
2.8%
7
6.7%
2
6
5.6%
13
12.5%
3
11
10.3%
8
7.7%
4
4
3.7%
6
5.8%
5
8
7.5%
9
8.7%
6
1
0.9%
3
2.9%
7
5
4.7%
2
1.9%
8
3
2.8%
4
3.8%
9
0
0%
0
0%
10
1
0.9%
5
4.8%
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
0
51
47.7%
55
52.9%
1
5
4.7%
7
6.7%
2
5
4.7%
7
6.7%
3
7
6.5%
7
6.7%
4
7
6.5%
5
4.8%
5
4
3.7%
5
4.8%
6
6
5.6%
1
1%
7
0
0%
2
1.9%
8
4
3.7%
6
5.8%
9
0
0%
3
2.9%
10
1
0.9%
2
1.9%
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
0
14
13.1%
15
14.4%
1
5
4.7%
6
5.8%
2
8
7.5%
8
7.7%
3
12
11.2%
12
11.5%
4
12
11.2%
11
10.6%
5
26
24.3%
26
25%
6
6
5.6%
7
6.7%
7
7
6.5%
7
6.7%
8
5
4.7%
5
4.8%
9
2
1.9%
2
1.9%
10
0
0%
0
0%
6. Secondary Outcome
Title Change in Blood Pressure
Description Mean arterial blood pressure using a blood pressure cuff
Time Frame 20 minutes post-visit

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [mm HG]
1.01
(10.7)
-.04
(8.07)
7. Secondary Outcome
Title Change in Heart Rate
Description Radial pulse
Time Frame 20 minutes post-visit

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [BPM]
.48
(11.68)
-.4
(8.02)
8. Post-Hoc Outcome
Title Change in Anxiety Score
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: For the intervention group, the patient interacts with the therapy dog, the handler shares information about the therapy dog, asks about the patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [units on a scale]
-1.13
(2.46)
-0.11
(2.60)
9. Post-Hoc Outcome
Title Change in Depression Score
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: For the intervention group, the patient interacts with the therapy dog, the handler shares information about the therapy dog, asks about the patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [units on a scale]
-0.72
(1.71)
0.02
(1.77)
10. Post-Hoc Outcome
Title Change in Well-Being Score
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description Patient interacts with the therapy dog and handler. Therapy Dog Team Visit: For the intervention group, the patient interacts with the therapy dog, the handler shares information about the therapy dog, asks about the patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit. No patient interaction with the therapy dog or handler.
Measure Participants 97 101
Mean (Standard Deviation) [units on a scale]
-0.87
(1.84)
0.14
(1.84)

Adverse Events

Time Frame
Adverse Event Reporting Description 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.
Arm/Group Title Therapy Dog Team Visit No Therapy Dog Team Visit
Arm/Group Description 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. No patient interaction with the therapy dog or handler.
All Cause Mortality
Therapy Dog Team Visit No Therapy Dog Team Visit
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Therapy Dog Team Visit No Therapy Dog Team Visit
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Therapy Dog Team Visit No Therapy Dog Team Visit
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Colleen Dell
Organization University of Saskatchewan
Phone 306-966-5912
Email Colleen.Dell@usask.ca
Responsible Party:
Colleen Dell, Research Chair in One Health & Wellness, Professor, Tenured, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT04727749
Other Study ID Numbers:
  • 1253
First Posted:
Jan 27, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021