NCT07227181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
Last Updated

November 12, 2025

Status Verified

October 1, 2025

Enrollment Period

21 days

First QC Date

November 9, 2025

Last Update Submit

November 9, 2025

Conditions

Keywords

Animal-Assisted TherapyTherapy DogTrauma PatientsEarly MobilizationAnxiety ReductionPain ReductionHuman-Animal Interaction

Outcome Measures

Primary Outcomes (6)

  • Change in Defense & Veterans Pain Rating Scale

    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.

    baseline and post intervention (1 day)

  • Change in General Anxiety Disorder-7 (GAD-7) Scale

    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 0 to 21, with higher values reflecting more severe anxiety symptoms.

    Baseline and post intervention (1 day)

  • General status

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

    baseline and post intervention (1 day)

  • Willingness to mobilize

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

    baseline and post intervention (1day)

  • Mobilization difficulty

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

    Baseline and post intervention (1 day)

  • Overall mobility satisfaction

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

    Baseline and post intervention (1 day)

Study Arms (1)

Animal-assisted intervention

EXPERIMENTAL

Trauma patients participating in Animal Assisted Intervention

Other: Therapy DogOther: Standard mobilization

Interventions

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

Animal-assisted intervention

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

Animal-assisted intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40515-9578, United States

Location

MeSH Terms

Conditions

Anxiety DisordersWounds and InjuriesHuman-Animal Interaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Andrew Bernard, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2025

First Posted

November 12, 2025

Study Start

July 23, 2025

Primary Completion

August 13, 2025

Study Completion

August 23, 2025

Last Updated

November 12, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations