Menu
Recruiting NCT07227181

Animal Assisted Therapy

No phase Interventional Anxiety Trauma Hospitalized Adult Patients Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapy Dog, Standard mobilization.
Who it may be relevant to
Registry conditions: Anxiety, Trauma, Hospitalized Adult Patients, Rehabilitation. Basic parameters: 4 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Change in Defense & Veterans Pain Rating Scale [Time frame: baseline and post intervention (1 day)]
  • Change in General Anxiety Disorder-7 (GAD-7) Scale [Time frame: Baseline and post intervention (1 day)]
  • General status [Time frame: baseline and post intervention (1 day)]
  • Willingness to mobilize [Time frame: baseline and post intervention (1day)]
  • Mobilization difficulty [Time frame: Baseline and post intervention (1 day)]
  • Overall mobility satisfaction [Time frame: Baseline and post intervention (1 day)]
  • Change in Wong-Baker Faces Scale [Time frame: Baseline and post intervention (1day)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kentucky Albert B. Chandler Hospital — Lexington

Identifiers

NCT: NCT07227181 · 104486

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗