AnxietyNCT07227181
Animal Assisted Therapy
A study testing Therapy Dog and Standard mobilization in people with Anxiety and Trauma, run by Andrew Bernard at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 99 years
- Conditions the study is for
- Anxiety, Trauma, Hospitalized Adult Patients
- What is being tested?
- Therapy Dog and Standard mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (18 years of age and older)
- trauma patients
- emergency general surgery patients
- pediatric patients (4 - 17 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, 40515-9578
Jessica C Borzansky, 8593586642, jcbo251@uky.edu
Andrew C Bernard, MD, andrew.bernard@uky.edu
About this study
Official title: Effects of Animal-Assisted Therapy on Trauma Patient's Willingness to Participate in Ambulation
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.
Read the 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.
- Conditions
- Anxiety, Trauma, Hospitalized Adult Patients, Rehabilitation, Physical Mobility Impairment, Therapy Dog
- Being tested
- Therapy Dog, Standard mobilization
- Keywords
- Animal-Assisted Therapy, Therapy Dog, Trauma Patients, Early Mobilization, Anxiety Reduction, Pain Reduction, Human-Animal Interaction
- Medical subject headings
- Anxiety Disorders, Wounds and Injuries, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy DogOther
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 mobilizationOther
Patients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. Standard mobilization no therapy dog is present
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted intervention | Experimental | Trauma patients participating in Animal Assisted Intervention Receives: Other: Therapy Dog; Other: Standard mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 not at all, a litte, some, a lot, with higher values reflecting more severe anxiety symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post intervention (1 day)
Change in Wong-Baker Faces Scale
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.
Measured: Baseline and post intervention (1day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start23 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Bernard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Bernard, University of Kentucky
- Investigators
- Andrew Bernard, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227181
- Sponsor's protocol ID
- 104486
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Animal-Assisted Therapy on Trauma Patient's Willingness to Participate in Ambulation
- ClinicalTrials.gov ID
- NCT07227181
- Acronym / sponsor ID
- 104486
- 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 type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Andrew BernardUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted intervention | Experimental | Other: Therapy Dog, Other: Standard mobilizationTrauma patients participating in Animal Assisted Intervention |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18 years of age and older)
- trauma patients
- emergency general surgery patients
- pediatric patients (4 - 17 years old)
Key exclusion criteria (7 listed)
- weight bearing limitation
- spine instability
- oxygen requirement >2LPM, GCS <15,
- high fall risk (as evidenced by door label)
- fear of dogs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy DogPatients 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 | Animal-assisted intervention |
| Standard mobilizationPatients assigned to AAI in the morning received standard mobilization in the afternoon, and vice versa. Standard mobilization no therapy dog is present | Other | Animal-assisted intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Bernard, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Dog and Standard mobilization in people with Anxiety and Trauma, run by Andrew Bernard at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Bernard, MD (8593236346, andrew.bernard@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Defense & Veterans Pain Rating Scale (time frame: baseline and post intervention (1 day)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.