A Study of the Pawsitive Impacts of Therapy Dog Visits With Adult Emergency Department Pain Patients
Phase: NA
Conditions: Pain, Pain, Acute, Pain, Chronic, Pain, Intractable
Sponsor: University of Saskatchewan

Study Protocol 
A Study of the ‘Pawsitive’ Impacts of 
Therapy Dog Visits with Adult Emergency 
Department Pain Patients 
Colleen Dell 
University of Saskatchewan 
April 22, 2019 
NCT04727749 

Behavioural Application
Page 1 of 11
03 December 2018 
Behavioural Application 
For Internal Use Only 
UnivRS Internal ID: 
Date Received: Click here to enter a date.
PART 1: KEY INFORMATION
Title*: A Study of the ‘Pawsitive’ Impacts of Therapy Dog Visits with Adult Emergency 
Department Pain Patients 
Level of Risk: * Minimal risk 
Expected Start Date: * 2019-06-01 
Expected End Date: * 2019-11-30 
If applicable, explain why this application is time sensitive: The RUH ED will move to its new 
location in November, 2019. We cannot collect data in two different locations with our 
control design. Also, our SCPOR funded researcher organizing the study and the data 
collection lead is only funded until November, 2019.  We just received notice of our 
funding at the start of this month.
Project Personnel
Principal Investigator
Name: 
NSID:  
Email:  
Phone:  
Organization 
(Department): 
Colleen Anne 
Dell
Cad924
Colleen.dell@usask.ca
5912
Sociology 
Sub-Investigator(s) 
Name: 
NSID:  
Email:  
Phone:  
Organization 
(Department): 
James 
Stempien
Jas510
Stempien@islandnet.com
306-220-
8618
Emergency 
Medicine
Eloise Carr 
N/A 
ecarr@ucalgary.ca 
403-220-
6267 
Faculty of Nursing 
Susan 
Tupper 
Smt677 
Susan.tupper@usask.ca 
306-655-
1041 
Saskatchewan 
Health Authority 
Peter Butt 
Prb984 
Peter.butt@usask.ca 
306-655-
0452 
U of S Medicine 
(Family medicine) 

Behavioural Application
Page 2 of 11
03 December 2018 
Donna 
Goodridge 
dpg031
Donna.goodridge@usask.ca
306-966-
4209 
U of S Medicine  
Jane Smith 
N/A 
smithpj@sasktel.net 
306-491-
4857 
St. Johns 
Ambulance, Royal 
University Hospital 
Lindsey 
Broberg  
Lja766 
Lja766@mail.usask.ca 
306-261-
7396 
Obstetrics and 
Gynecology 
Resident 
Benjamin 
Carey 
Bdc114 
Bdc114@mail.usask.ca 
306-380-
7338 
Sociology  
Alicia 
Husband 
Akh671 
alicia.husband@usask.ca 
966-6717 
Sociology 
Lacey Jerk 
Lcj050 
lcj050@mail.usask.ca 
College of Medicine
Beverly 
Morrison 
Bjm194 
Bjm194@mail.usask.ca 
966-7237 
Veterinary 
Microbiology 
Betty Rohr 
Bar123
Betty.rohr@usask.ca 
966-8548
Sociology 
Student(s) 
Name: 
NSID:  
Email:  
Phone:  
Organization 
(Department): 
Primary Contact 
Name: 
NSID:  
Email:  
Phone:  
Organization 
(Department): 
Secondary Contact 
Name: 
NSID:  
Email:  
Phone:  
Organization 
(Department): 
Sponsor(s)   
Sponsor: 
Pending / Awarded 

Behavioural Application
Page 3 of 11
03 December 2018 
RUH Foundation
20,000
Agency(ies) 
This project is funded: *
 Yes   
 No 
The funding supporting this project will be administrated at the 
University of Saskatchewan:  
 Yes, complete Part A 
 No, complete Part B 
Part A: For Grants and Contracts administered by the U of S: 
Project Application(s) Directly Associated with the Fund(s) Supporting this Project  
Specify the UnivRS internal ID# (for pending grants or contracts): 
Project(s) Directly Associated with the Fund(s) Supporting this Project 
Specify the UnivRS internal ID# (for awarded grants or contracts): 
Part B: For Grants or Contracts not administered by the U of S:
Agency: 
Pending / Awarded 
RUH 
Foundation
20,000
Location(s) Where Research Activities Are Conducted  
Enter every location where this research will be conducted under this Research Ethics Approval: * 
Royal University Hospital Emergency Department
Country(ies):* List all countries where you will be conducting your research under this Research Ethics 
Approval:  Canada
If this project will be conducted within schools, health regions, or other organizations, specify how 
you will obtain permission to access the site. Submit a copy of the certificate or letter of approval 
when obtained. Letter of approval has been obtained (see attached)
If you do not plan to seek approval, provide a justification: 
Other Ethics Approval 
This project has applied for/received approval from another Research Ethics 
Board(s) *
 Yes   
 No 
 If 'yes', identify the other Research Ethics Board(s): 
Conflict of Interest 
Confirm whether any member of the research team or their immediate family members will:
Receive personal benefits over and above the direct costs of conducting the 
project, such as remuneration or employment: *
 Yes   
 No 
Receive significant payments from the Sponsor such as compensation in the form 
 Yes   
 No 

Behavioural Application
Page 4 of 11
03 December 2018 
of equipment, supplies or retainers for ongoing consultation and honoraria: *
Have a non-financial relationship with the Sponsor such as unpaid consultant, 
board membership, advisor or other non-financial interest: *
 Yes   
 No 
Have any direct involvement with the Sponsor such as stock ownership, stock 
options or board membership: *
 Yes   
 No 
Hold patents, trademarks, copyrights, licensing agreements or intellectual 
property rights linked in any way to this project or the Sponsor: *
 Yes   
 No 
Have any other relationship, financial or non-financial, that if not disclosed, could 
be construed as a conflict of interest: *
 Yes   
 No 
If yes was answered to any question(s), explain the personal benefit(s) and how the conflict will be     
managed: 
Part 2: PROJECT OVERVIEW
Project Overview 
Summarize this project, its objectives and potential significance: 
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. 
Provide a description of the research design and methods to be used:
St. John Ambulance Therapy Dog teams are comprised of a certified (tested and passed) therapy dog 
and handler. The goal of the St. Johns Ambulance therapy dog program is to offer support and 
comfort to individuals the dogs visit with. Five therapy dog teams commonly visit the RUH ED five 
days a week. The visits follow a standardized protocol (i.e., sign in, patients interact with the therapy 
dog, handlers share information about the dog). In this study therapy dogs will visit a convenience 
sample of consenting RUH ED pain patients five days a week. Each therapy dog team will participate 
once-a-week, for a 90 minute period, and during peak and low patient ED wait times (by day of the 
week and time). Participants will be over the age of 18, able to provide consent, attending the ED 
because of pain and want to visit with a therapy dog. These patients are located in the ‘active area’ of 
the ED in individual curtained-off spaces with beds; the patients are either waiting to be seen by a 
physician, have treatment in progress, or are admitted to hospital and waiting for a unit bed. A 

Behavioural Application
Page 5 of 11
03 December 2018 
control group will also be involved, with the same process and sample.
Data will be collected 3 days/ week (alternating with control days). Data will be collected in five steps, 
using quantitative psychometric measures that will not exceed 10 minutes. Patient pain will be 
measured with the Edmonton Symptom Assessment System (revised version) (ESAS-R) (numerical 
pain scale) and patient anxiety will be measured with biomarkers (heart rate, blood pressure) and the 
ESAS-R (anxiety, depression and overall wellbeing questions). The Human-Animal Interaction Scale 
(HAIS) will be applied to document the behaviour and amount of interaction between the therapy dog 
and patient. Quantitative data analysis using both descriptive and inferential statistical procedures 
will be conducted to examine distributions, relationships and differences among variables. Measures 
of outcome variables will be compared between pre- and post-therapy dog intervention and the 
influence of moderator variables, such as gender, will be examined. The HAIS score will indicate the 
quantity of positive human-animal interaction.  
Control group data will be collected 2 days/ week (alternating with animal testing days) with a goal of 
8 samples per day. The data collection will occur in two stages. First, patient pain will be measured 
with the Edmonton Symptom Assessment System (revised version) (ESAS-R) (numerical pain scale) 
and patient anxiety will be measured with biomarkers (heart rate, blood pressure) and the ESAS-R 
(anxiety, depression and overall wellbeing questions). The HAIS scale will not be administered during 
the control as there will be no animal interaction. Control days require two research assistants who 
will obtain consent 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. 
All of our team members will meet on a monthly basis. The team represents a solid compliment of 
expertise, experience and knowledge (contributing from data collection through to end-of-grant 
knowledge translation). This will enable the team to fully deliver on the project goal, purpose and 
objectives. The outcomes of this study will be meaningfully translated and disseminated to improve 
the health care of RUH ED pain patients with peer reviewed publishing, RUH monitor adverts and 
webinar, and a news release. The clinical relevance of this study is that the outcomes will offer a 
complementary understanding of quality health care for ED pain patients. To date there have been no 
studies of therapy dogs in EDs in Canada. 
Duration and Location of Data Collection Events 
Outline the duration and location of data collection for the following, if applicable:
Audio/Video Recording(s):       
Ethnography:       
Focus Group(s):       
Group Interview(s):       
Home Visit(s):       
Individual Interview(s):  
Non-Invasive Physical Measurement(s): Anxiety will be measured using biomarkers: heart rate and 
blood pressure. All measurements will be taken by a trained RA before the visit, during and 15 

Behavioural Application
Page 6 of 11
03 December 2018 
minutes after the visit.
Participant Observation:  
Questionnaire(s): Once a candidate is identified and before the visit takes place, participants will be 
asked by the RA to complete the pain, anxiety and demographic questions (Edmonton Symptom 
Assessment System (revised version) (ESAS-R) (numerical pain scale) (see attached). After the therapy 
dog visit the patient will be asked to complete the HAIS. Fifteen minutes post visit the participant will be 
asked to complete the pain and anxiety questions for a second time. 
Secondary Use of Data or Analysis of Existing Data:       
Other: 
Internet-Based Interaction 
Confirm whether this project will involve internet-based interactions with 
participants, including e-mails: * 
 Yes   
 No 
If a third party research or transaction log tool, screen capturing or website survey software or 
masked survey site is used, describe how the security of data gathered at those sites will be ensured: 
Describe how permission to use any third party owned site(s) will be obtained: 
If participants may be identified by their email address, IP address or other identifying information, 
explain how this information will remain private and confidential: 
Anonymity and Confidentiality 
Confirm whether participants will be anonymous in the data gathering phase of 
the project: *
 Yes   
 No 
If 'No' was answered to the previous question, explain how the confidentiality of participants and 
their data will be protected, and include whether the research procedures or collected information 
may reasonably be expected to identify an individual:  
All participants will be given an identifier on their data collection sheets, and no identifying 
information will be collected. 
Identify any factors that may limit the researchers’ ability to guarantee confidentiality:
Limits due to the nature of group activities, such as a focus group where the 
project team cannot guarantee confidentiality: 
 Yes   
 No 
Limits due to context: individual participants could be identified because of the 
nature or size of the sample: 
 Yes   
 No 
Limits due to context: individual participants could be identified because of their 
relationship with the project team: 
 Yes   
 No 
Limits due to selection: procedures for recruiting or selecting participants may 
compromise the confidentiality of participants, such as those referred to the 
project by a person outside the project team:   
 Yes   
 No 
Other confidentiality limits: 
Risks and Benefits 

Behavioural Application
Page 7 of 11
03 December 2018 
Explain the psychological, emotional, physical, social or legal harms that participants may experience 
during or after their participation: The study has three minor ethical issues. First is the perceived risk 
of zoonotic disease transmission in the ED.  
Second is the potential negative patient reaction to a therapy dog presence in the ED.   
Third, there may be some minimal discomfort experienced by patients in taking their anxiety 
biomarkers.   
Describe how the above risks will be managed. If appropriate, identify any resources to which they 
can be referred: 
First, during the pilot study the team applied the American Veterinary Medical Association therapy 
dog visiting guidelines and we developed RUH ED specific visiting protocols. These will apply to the 
proposed study. We also have the expertise of Dr. Joe Rubin (Professor Veterinary Microbiology) on 
our research advisory group.  
Second, Policies and procedures have been developed to ensure the health and safety of patients, 
staff, therapy dogs and handlers (e.g., approaching patients upon consent, signage in the ED). Our 
team also conducted a patient study in the ED waiting room in 2017 and found that more than 80% of 
participants agreed or strongly agreed that people would want to visit a therapy dog. 
Third, the discomfort experienced by patients in taking their anxiety biomarkers is minimal and not 
out of the ordinary of regular ED procedures.
IT IS IMPORTANT TO NOTE that the therapy dogs regularly visit the RUHD ED, and have been doing so 
for three years, irrespective of this study.  
Describe the likely benefits of the research that may justify the above risk(s): The clinical relevance 
and benefits of this study to RUH pain patients is grounded in recognition of the potential benefits of 
animals in human pain patient health care in the ED. Examining the impact of a unique psychosocial 
health intervention on pain patients’ experiences in a hospital ED can offer a complementary 
understanding of quality health care. There have been no studies of therapy dogs in EDs in Canada, 
one opinion survey in the US has been undertaken, and a recent (2019) controlled trial in a US ED 
department with therapy dogs. The US opinion study found that “93% of patients and 95% of staff 
agreed that therapy dogs should visit EDs". This finding highlights what is widely accepted in the 
companion animal literature but infrequently by ED medicine and medicine generally; interacting with 
animals can benefit human bio-psycho-social-spiritual health. The controlled study found that 
“Exposure to therapy dogs plus handlers significantly reduced anxiety in ED patients”. 
Part 3: Community Engagement 
Aboriginal Peoples and Community Engagement 
Aboriginal communities, peoples, language, culture or history is the primary 
focus of this project: *
 Yes   
 No 
Aboriginal people will comprise a sizable proportion of the larger community 
that is the subject of research even if no Aboriginal-specific conclusions will 
be made:  *
 Yes   
 No 
 Not Applicable 

Behavioural Application
Page 8 of 11
03 December 2018 
There is an intention to draw Aboriginal-specific conclusions from this 
project: *
 Yes   
 No 
This project will  involve community-based participatory research: *
 Yes   
 No 
There will be a research agreement between the researcher and community:
 Yes   
 No 
Aboriginal Engagement and Community-Based Participatory Research 
If 'yes' was answered to any of the above questions, complete the following:
Outline the process to be followed for consulting with the appropriate community: 
Describe the organizational structure and community processes required to obtain approval within 
the specific community(ies): 
Describe any customs and codes of research practice that apply to the particular community(ies) 
affected by the project: 
Describe how the research plan will consider mutual benefit to the participating community(ies), 
support capacity building through enhancement of the skills of community personnel and the 
recognition of the role of elders and other knowledge holders: 
Describe how the community representatives will have the opportunity to participate in the 
interpretation of the data and the review of research findings before the completion of any reports or 
publications: 
Describe how the final project results will be shared with the participating community(ies): 
PART 4: RECRUITMENT AND CONSENT
Participant Recruitment 
Indicate the expected number of participants and provide a brief rationale for the number: 
A sample size of at least 122 in both the control and animal intervention is required to detect 
statistically significant results based on information collected on patient response in the pilot study.  
Describe the criteria for including participants:
Participants will be over the age of 18, able to provide consent, attending the ED because of pain and 
want to visit with a therapy dog. These patients are located in the ‘active area’ of the ED in individual 
curtained-off spaces with beds; the patients are either waiting to be seen by a physician, have 
treatment in progress, or are admitted to hospital and waiting for a unit bed. Participants will also be 
willing to visit with a therapy dog team (although the control group will not be visiting with a dog).  
Describe the criteria for excluding participants:
The RA will access the patient’s Medication Administration Record (MAR) to confirm non-
administration of pain medications (specifically immediate release acetaminophen and opioid 
analgesics) within the hour prior to the visit. This step is included to prevent confounding the 
potential effect of the therapy dog intervention on pain outcomes. 
Provide a detailed description of the method of recruitment, such as how and whom will identify and 
contact prospective participants:  

Behavioural Application
Page 9 of 11
03 December 2018 
RA #1 will identify patients who are verbally coherent and interested in visiting with a therapy dog. 
Consent will be obtained from pain patients to participate in the study. All ED patients can visit with a 
therapy dog, regardless of study participation. The RA will access the patient’s Medication Administration 
Record (MAR) to confirm non-administration of pain medications (specifically immediate release 
acetaminophen and opioid analgesics) within the hour prior to the visit. This step is included to prevent 
confounding the potential effect of the therapy dog intervention on pain  
Outcomes.
If the project involves vulnerable, distinct, or cultural groups, or if the project is above minimal risk, 
describe the research team's experience or training in working with the population: N/A
Explain any relationship between the researchers and the participants, including any safeguards to 
prevent possible undue influence, coercion or inducement:  
All questions are pre written and many are established instruments such as the Human Animal 
Interaction questionnaire. The participant can also have the option of filling out the questions on their 
own. Participant answers and identity will be kept anonymous.
Provide the details of any compensation or reimbursements offered to the participants: N/A
Consent Process 
Describe the consent process:
Consent form attached, RA #1 will explain the form and how the information gathered will be used.
Specify who will explain the consent form and consent participants:  
Research assistant #1 will explain the form before the therapy dog visit is conducted. If the individual 
does not consent to the research they will still be allowed to visit with the therapy dog. 
Explain where and under what circumstances consent will be obtained from participants:
Consent will be obtained from each person before the data is collected, and before the therapy dog 
visit.
Describe any situation where the renewal of consent might be appropriate and how it may be  
obtained: * N/A 
If deception of any kind will be used, justify its use, describe the protocol for debriefing and re-
consenting participants upon completion: Deception will be used on days where control data is 
collected. Participants will sign a consent form that indicates the study they are signing off on will be 
about the impacts of psychosocial intervention in emergency pain patients. The deception is used to 
guarantee the patients pain and anxiety be unaffected by any knowledge of therapy dogs or that they 
are part of a control group. Once all the data needed is gathered from the participant they will be 
explained the deception and given another consent form to sign with the true information regarding 
the study.
If any of the participants are not competent to consent, describe the process by which their capacity or 
competency will be assessed, identify who will consent on his/her behalf (including any permission or 
information letter to be provided to the person or persons providing alternate consent), as well as the 
assent process for participants: N/A
Describe how and when participants will be informed about their right to withdraw, including the 
procedures to be followed for participants who wish to withdraw at any point during the project:  
Participants will be informed about their right to withdrawal at the time the consent form is given and 

Behavioural Application
Page 10 of 11
03 December 2018 
explained. Participants can withdraw at any point from the study up until the data is analyzed.
PART 5: SECURITY AND STORAGE
Data Security and Storage 
Identify the research personnel responsible for data collection: 
Benjamin Carey and Alicia Husband
Specify who will have access to raw data, which may include information that would identify 
participants:  
Colleen Dell, Benjamin Carey and Alicia Husband
Describe the data storage plans, including the arrangements for preventing the loss of data:  
Data will be uploaded to an external hard drive and all paper data will be stored in a locked container.
Confirm whether the Principal Investigator will be responsible for data storage: *
Yes   
No
If no, specify the reasons and indicate who will be responsible for data storage: 
Specify how long data will be retained:  
5 years minimum as per University of Saskatchewan Guidelines 
If other, specify duration and provide justification: 
Explain how the collected data is intended to be published, presented, or reported:  
Peer-reviewed article writing, presentation at the Canadian Association of Emergency Physicians 
conference (if external funding is secured), and end-of-grant knowledge translation. 
Describe the final disposition of research materials:  
*Any paper copies will be shredded and saved data will be destroyed (erased). 
State whether data will be transferred to a third party: *
Yes   
No
Organization(s) where data will be transferred: 
Indicate how data will be transferred to the third party: Choose an item.
If other, please specify: 
PART 6: DECLARATION OF PRINCIPAL INVESTIGATOR 
By submitting this application form, the Principal Investigator (PI) attests to the following: 

the information provided in this application is complete and correct. 

the PI accepts responsibility for the ethical conduct of this project and for the protection of 
the rights and welfare of the human participants who are directly or indirectly involved in this 
project. 

the PI will comply with all policies and guidelines of the University and affiliated institutions 
where this project will be conducted, as well as with all applicable federal and provincial laws 
regarding the protection of human participants in research. 

the PI will ensure that project personnel are qualified, appropriately trained and will adhere 
to the provisions of the Research Ethics Board-approved application. 

Behavioural Application
Page 11 of 11
03 December 2018 

that adequate resources to protect participants (i.e., personnel, funding, time, equipment and 
space) are in place before implementing the research project, and that the research will stop 
if adequate resources become unavailable. 

any changes to the project, including the proposed method, consent process or recruitment 
procedures, will be reported to the Research Ethics Board for consideration in advance of 
implementation. 

will ensure that a status report will be submitted to the Research Ethics Board for 
consideration within one month of the current expiry date each year the project remains 
open, and upon project completion. 

if personal health information is requested, the PI assures that it is the minimum necessary to 
meet the research objective and will not be reused or disclosed to any parties other than 
those described in the Research Ethics Board-approved application, except as required by 
law. 

if a contract or grant related to this project is being reviewed by the University or Health 
Region, the PI understands a copy of the application, may be forwarded to the person 
responsible for the review of the contract or grant. 

if the project involves Health Authority resources or facilities, a copy of the ethics application 
may be forwarded to the Health Authority research coordinator to facilitate operational 
approval. 
DOCUMENT(S) 
Please provide a list of documents that are being submitted along with this application: e.g. Consent 
forms, questionnaires, interview questions, data collection sheets, recruitment materials. 
Consent form (visit with the Therapy Dog) 
Consent form (not visit with the Therapy Dog) 
St. John Ambulance Therapy Dog Program Letter of Support 
Saskatoon Health Region Letter of Support 
Data collection tools 
-ESAS-R (indicate on picture; scale 1-10) 
-Main reason for attending the ED 
-Heart rate and blood pressure 
-ESAS-R numerical scale (anxiety, depression, wellbeing) 
-Patient demographics 
-HAIS form