- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812247
Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries
June 5, 2025 updated by: Boston Medical Center
Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression.
Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate.
However, few studies have investigated the role of AAT in the post-operative course in adults.
This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized control design.
Within 48 hours of admission, the study team will approach eligible patients admitted to the inpatient trauma service to discuss the study and obtain informed consent from patients expected to be admitted for 3-7 days.
Consenting patients will be randomized to either a) participate in 2-3 ten-minute dog visits or b) receive 2-3 ten-minute visits with a handler alone.
Within 24 hours after the last anticipated study visit, a member of the study team will administer a survey to assess participants' pain, depression, anxiety, mood, and emotional quality of life.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabrina Sanchez, MD MPH
- Phone Number: 617 414 4861
- Email: sabrina.sanchez@bmc.org
Study Contact Backup
- Name: Sara Myers, MD
- Phone Number: 617 638 9191
- Email: sara.myers@bmc.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Recruiting
- Boston Medical Center, Trauma Inpatient Service
-
Contact:
- Sara Myers, MD
- Phone Number: 617 638 9191
- Email: sara.myers@bmc.org
-
Contact:
- Sabrina Sanchez, MD MPH
- Phone Number: 617-414-4861
- Email: sabrina.sanchez@bmc.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
- English or Spanish speaking
- Able to provide informed consent
Exclusion Criteria:
- Fear of dogs, allergy to dogs
- Immunocompromised
- Contact precautions
- Delirious, intubated, or otherwise unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Therapy dog visits
Participants randomized into this arm will receive visits from a therapy dog and their handler during hospitalization.
|
2-3 ten-minute visits by a trained therapy dog and the dog's handler
|
|
Active Comparator: Dog handler visits
Participants randomized into this arm will receive visits from a dog handler during hospitalization.
|
2-3 ten-minute visits by a dog handler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants' pain assessed with a numeric analog score
Time Frame: 24 hours after the last study visit
|
The visual analog score ranges from 0 to 10 where 0= no pain and 10 worst pain (5= moderate pain).
|
24 hours after the last study visit
|
|
Participants' pain assessed with pictures of facial expressions
Time Frame: 24 hours after the last study visit
|
The 6 facial pictorial expressions range from 0 to 10 where 0 is a face with a broad smile and 10 is a very sad face with tears.
|
24 hours after the last study visit
|
|
Depression assessed by the Brief Mood Survey
Time Frame: 24 hours after the last study visit
|
There are 5 questions related to feeling depressed in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'.
The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain and higher scores are associated with feeling more depressed.
|
24 hours after the last study visit
|
|
Anxiety assessed by the Brief Mood Survey
Time Frame: 24 hours after the last study visit
|
There are 5 questions related to feeling anxious in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'.
The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain, and higher scores are associated with feeling more anxious.
|
24 hours after the last study visit
|
|
Anger assessed by the Brief Mood Survey
Time Frame: 24 hours after the last study visit
|
There are 5 questions related to feeling angry in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'.
The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain, and higher scores are associated with feeling more angry.
|
24 hours after the last study visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional quality of life now
Time Frame: 24 hours after the last study visit
|
The Emoqol-100 will be used to assess emotional quality of life.
It is one question, 'How is your emotional quality of life now, with 100 being perfect and 0 being the worst imaginable?' Higher numbers are associated with a better quality of life.
|
24 hours after the last study visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sabrina Sanchez, MD MPH, Boston Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
February 1, 2025
First Submitted That Met QC Criteria
February 1, 2025
First Posted (Actual)
February 6, 2025
Study Record Updates
Last Update Posted (Actual)
June 6, 2025
Last Update Submitted That Met QC Criteria
June 5, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H45457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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