2025 Animal Assisted Therapy

NCT ID: NCT07227181

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2025-08-23

Brief Summary

This study looks at whether walking with a therapy dog helps adult 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), 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

Conditions

Anxiety; Trauma; Hospitalized Adult Patients; Rehabilitation; Physical Mobility Impairment; Therapy Dog

Keywords

Animal-Assisted Therapy; Therapy Dog; Trauma Patients; Early Mobilization; Anxiety Reduction; Pain Reduction; Human-Animal Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Animal-assisted intervention

Trauma patients participating in Animal Assisted Intervention

Group Type: EXPERIMENTAL

Therapy Dog

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (18 years of age and older)
• trauma patients

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrew Bernard

OTHER

Sponsor Role: lead

Responsible Party

Andrew Bernard

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew Bernard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

104486

Identifier Type: -

Identifier Source: org_study_id