Trauma InjuryNCT06812247
Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries
A study testing Therapy dog visits and Dog handler visits in people with Trauma Injury and Depression, run by Boston Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Depression, Anxiety
- What is being tested?
- Therapy dog visits and Dog handler visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
- English or Spanish speaking
- Able to provide informed consent
Who cannot join
- Fear of dogs, allergy to dogs
- Immunocompromised
- Contact precautions
- Delirious, intubated, or otherwise unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center, Trauma Inpatient Service
Boston, Massachusetts, 02118
Sabrina Sanchez, MD MPH, 617-414-4861, sabrina.sanchez@bmc.org
Sara Myers, MD, 617 638 9191, sara.myers@bmc.org
About this study
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).
Read the 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.
- Conditions
- Trauma Injury, Depression, Anxiety, Anger, Pain
- Being tested
- Therapy dog visits, Dog handler visits
- Keywords
- Therapy dogs, Healing pups, Animal assisted therapy (AAT), Traumatic injuries recovery
- Medical subject headings
- Accidental Injuries, Depression, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy dog visitsOther
2-3 ten-minute visits by a trained therapy dog and the dog's handler
Dog handler visitsOther
2-3 ten-minute visits by a dog handler
| Study group | Role | What they receive |
|---|---|---|
| Therapy dog visits | Experimental | Participants randomized into this arm will receive visits from a therapy dog and their handler during hospitalization. Receives: Other: Therapy dog visits |
| Dog handler visits | Active comparator | Participants randomized into this arm will receive visits from a dog handler during hospitalization. Receives: Other: Dog handler visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' pain assessed with a numeric analog score
The visual analog score ranges from 0 to 10 where 0= no pain and 10 worst pain (5= moderate pain).
Measured: 24 hours after the last study visit
Participants' pain assessed with pictures of facial expressions
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.
Measured: 24 hours after the last study visit
Depression assessed by the Brief Mood Survey
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.
Measured: 24 hours after the last study visit
Anxiety assessed by the Brief Mood Survey
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.
Measured: 24 hours after the last study visit
Anger assessed by the Brief Mood Survey
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.
Measured: 24 hours after the last study visit
Secondary outcomes (1)
Emotional quality of life now
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.
Measured: 24 hours after the last study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start4 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center Healing Pups Program
- Responsible party
- Sponsor
- Investigators
- Sabrina Sanchez, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812247
- Sponsor's protocol ID
- H45457
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries
- ClinicalTrials.gov ID
- NCT06812247
- Acronym / sponsor ID
- H45457
- Conditions
- Trauma Injury, Depression, Anxiety, Anger, Pain
- Keywords
- Therapy dogs, Healing pups, Animal assisted therapy (AAT), Traumatic injuries recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center Healing Pups Program
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy dog visits | Experimental | Other: Therapy dog visitsParticipants randomized into this arm will receive visits from a therapy dog and their handler during hospitalization. |
| Dog handler visits | Active comparator | Other: Dog handler visitsParticipants randomized into this arm will receive visits from a dog handler during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
- English or Spanish speaking
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Fear of dogs, allergy to dogs
- Immunocompromised
- Contact precautions
- Delirious, intubated, or otherwise unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy dog visits2-3 ten-minute visits by a trained therapy dog and the dog's handler | Other | Therapy dog visits |
| Dog handler visits2-3 ten-minute visits by a dog handler | Other | Dog handler visits |
Primary outcome
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).
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.
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.
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.
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.
1 secondary outcome
Emotional quality of life now
Time frame: 24 hours after the last study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Sanchez, MD MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy dog visits and Dog handler visits in people with Trauma Injury and Depression, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Sanchez, MD MPH (617 414 4861, sabrina.sanchez@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' pain assessed with a numeric analog score (time frame: 24 hours after the last study visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.