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临床试验/NCT07227181
NCT07227181招募中不适用

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

Andrew Bernard2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
2
主要终点
Change in Wong-Baker Faces Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Animal-assisted intervention

Experimental

Trauma patients participating in Animal Assisted Intervention

干预措施: Therapy Dog (Other)

Animal-assisted intervention

Experimental

Trauma patients participating in Animal Assisted Intervention

干预措施: Standard mobilization (Other)

结局指标

主要结局

Change in Wong-Baker Faces Scale

时间窗: 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.

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

时间窗: 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.

Change in Defense & Veterans Pain Rating Scale

时间窗: 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.

General status

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Andrew Bernard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andrew Bernard

Professor

University of Kentucky

研究点 (2)

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