Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries

NCT06812247 | Recruiting

• 1 other identifier: H45457
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Trauma Injury; Depression; Anxiety; Anger; Pain

Keywords

Therapy dogs; Healing pups; Animal assisted therapy (AAT); Traumatic injuries recovery

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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.

  24 hours after the last study visit

Secondary Outcomes (1)

• Emotional quality of life now

  24 hours after the last study visit

Study Arms (2)

Therapy dog visits

EXPERIMENTAL

Participants randomized into this arm will receive visits from a therapy dog and their handler during hospitalization.

Other: Therapy dog visits

Dog handler visits

ACTIVE COMPARATOR

Participants randomized into this arm will receive visits from a dog handler during hospitalization.

Other: Dog handler visits

Interventions

Therapy dog visits OTHER

2-3 ten-minute visits by a trained therapy dog and the dog's handler

Therapy dog visits

Dog handler visits OTHER

2-3 ten-minute visits by a dog handler

Dog handler visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
• English or Spanish speaking
• Able to provide informed consent

You may not qualify if:

• Fear of dogs, allergy to dogs
• Immunocompromised
• Contact precautions
• Delirious, intubated, or otherwise unable to consent

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston Medical Center Healing Pups Program: collaborator

Study Sites (1)

Boston Medical Center, Trauma Inpatient Service

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Accidental Injuries; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabrina Sanchez, MD MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Sanchez, MD MPH

CONTACT

617 414 4861; sabrina.sanchez@bmc.org

Sara Myers, MD

CONTACT

617 638 9191; sara.myers@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)