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NCT Number: NCT07227181

Animal Assisted Therapy

This study looks at whether walking with a therapy dog helps adult and pediatric trauma patients move more during their hospital stay. Early movement after an injury or surgery can prevent problems such as blood clots, pressure sores, and muscle loss, but pain and anxiety often make it hard for patients to get out of bed.

Each patient in this study takes part in two walking sessions-one with a certified therapy dog and one without a dog. The order is randomized, so some patients walk with the dog first and others walk without the dog first. Before and after each walk, patients fill out short surveys about their pain, anxiety, and motivation to move. The research team measures how far and how long each patient walks in both sessions.

The goal of this project is to see if therapy dog visits can safely and effectively improve mobility, reduce pain and anxiety, and make walking more enjoyable for trauma patients. Findings from this study may help hospitals design better rehabilitation programs that use animal-assisted therapy to support physical and emotional recovery.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Hospitalized Adult Patients Human-Animal Interaction Mental Disorders Pediatric Patient (1m-21y) Physical Mobility Impairment Rehabilitation Therapy Dog Trauma Wounds and Injuries

Age range

4 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40515-9578, United States

Location status: Recruiting

Location contact

Andrew C Bernard, MD

CONTACT

[email protected]

Jessica C Borzansky

CONTACT

[email protected]

8593586642

About this study

Early mobilization after traumatic injury is a key component of recovery and is associated with reduced complications, shorter hospital stays, and improved functional outcomes. However, trauma patients frequently experience significant barriers to early ambulation, including pain, anxiety, fatigue, and psychological distress following injury and surgery. Animal-assisted interventions (AAI) have demonstrated benefits in reducing pain and anxiety, enhancing mood, and improving patient motivation in various hospital settings. Despite these findings, limited research has examined the role of therapy dogs in promoting early mobility specifically among adult trauma inpatients.

This randomized crossover trial investigates the effect of animal-assisted ambulation on walking duration, distance, and patient-reported outcomes among adult trauma patients admitted to an academic Level I trauma center. Each enrolled participant completes two ambulation sessions within their hospital stay: one with the presence of a certified therapy dog and handler, and one without a dog (standard physical therapy or nursing-led walk). The order of sessions is randomized to control for order effects, and all participants serve as their own control.

During each session, objective ambulation data-including walking duration (minutes), and assistance level-are recorded by the research team or physical therapy staff. Pre- and post-session self-report measures assess pain (DVPRS), Wong-Baker Faces scale (peds), anxiety (Modified GAD-7), and motivation to mobilize (Likert scale).

The study aims to evaluate whether therapy dog-assisted ambulation results in greater walking duration and distance, as well as reduced perceived pain and anxiety, compared to standard ambulation without a therapy dog. Secondary analyses will explore potential moderating effects of time of day, patient demographics, and mechanism of injury on intervention effectiveness.

All therapy dogs and handlers are registered through a national certification organization and follow strict infection control and safety protocols consistent with institutional policy. Data will be analyzed using mixed-effects models to account for within-subject correlations and to assess crossover effects.

This study is designed to inform evidence-based integration of animal-assisted therapy into trauma rehabilitation protocols, supporting both the physical and psychosocial dimensions of recovery in hospitalized trauma patients

Additional cohort of the study (pediatric trauma) population has been added.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (18 years of age and older)
  • trauma patients
  • emergency general surgery patients
  • pediatric patients (4 - 17 years old)

Exclusion criteria

  • weight bearing limitation
  • spine instability
  • oxygen requirement >2LPM, GCS <15,
  • high fall risk (as evidenced by door label)
  • fear of dogs
  • allergies to dogs
  • prisoners

Treatment and study plan

Therapy Dog

Other

Patients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. In the AAI intervention, patients interacted with the therapy dog and handler

Standard mobilization

Other

Patients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. Standard mobilization no therapy dog is present

Primary outcomes

  1. Change in Defense & Veterans Pain Rating Scale

    Time frame: baseline and post intervention (1 day)

    Before and after each intervention, patients completed surveys assessing pain using the (Defense and Veterans Pain Rating Scale, DVPRS). Scores on the scale ranged from 0: no pain to 10: worst pain of patient's life.

  2. Change in General Anxiety Disorder-7 (GAD-7) Scale

    Time frame: Baseline and post intervention (1 day)

    Before and after each intervention, patients completed surveys assessing anxiety using modified General Anxiety Disorder-7 (GAD-7). Scaled from not at all to a lot, resulting in a total score that can range from not at all, a litte, some, a lot, with higher values reflecting more severe anxiety symptoms.

  3. General status

    Time frame: baseline and post intervention (1 day)

    Before and after each intervention, patients completed surveys assessing general status. Used likert scale ranging from very poor to excellent.

  4. Willingness to mobilize

    Time frame: baseline and post intervention (1day)

    Before and after each intervention, patients completed surveys assessing willingness to mobilize. Used likert scale ranging from no motivation at all to very much.

  5. Mobilization difficulty

    Time frame: Baseline and post intervention (1 day)

    Before and after each intervention, patients completed surveys assessing mobilization difficulty. Used likert scale ranging from very easy to very hard.

  6. Overall mobility satisfaction

    Time frame: Baseline and post intervention (1 day)

    Before and after each intervention, patients completed surveys assessing overall mobility satisfaction. Used likert scale ranging from not satisfied to very satisfied.

  7. Change in Wong-Baker Faces Scale

    Time frame: Baseline and post intervention (1day)

    Before and after each intervention, pediatric patients will use Wong-Baker FACES Pain Rating Scale to assess pain. Scores on the scale ranged from 0: "no hurt" to 10: "hurts worst." Participants ages 4-7 will use a modified FACES and 8-17 will use a regular FACES.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Bernard, MD

CONTACT

[email protected]

8593236346

Sponsors and collaborators

Lead sponsor

Andrew Bernard

Other

Registry information

Official study title

Effects of Animal-Assisted Therapy on Trauma Patient's Willingness to Participate in Ambulation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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