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临床试验/NCT06812247
NCT06812247招募中不适用

Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年6月4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
入组人数
80
试验地点
2
主要终点
Participants' pain assessed with a numeric analog score

研究概览

简要总结

Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. However, few studies have investigated the role of AAT in the post-operative course in adults. This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC).

详细描述

This study will be a randomized control design. Within 48 hours of admission, the study team will approach eligible patients admitted to the inpatient trauma service to discuss the study and obtain informed consent from patients expected to be admitted for 3-7 days. Consenting patients will be randomized to either a) participate in 2-3 ten-minute dog visits or b) receive 2-3 ten-minute visits with a handler alone. Within 24 hours after the last anticipated study visit, a member of the study team will administer a survey to assess participants' pain, depression, anxiety, mood, and emotional quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma
  • English or Spanish speaking
  • Able to provide informed consent

排除标准

  • Fear of dogs, allergy to dogs
  • Immunocompromised
  • Contact precautions
  • Delirious, intubated, or otherwise unable to consent

研究组 & 干预措施

Therapy dog visits

Experimental

Participants randomized into this arm will receive visits from a therapy dog and their handler during hospitalization.

干预措施: Therapy dog visits (Other)

Dog handler visits

Active Comparator

Participants randomized into this arm will receive visits from a dog handler during hospitalization.

干预措施: Dog handler visits (Other)

结局指标

主要结局

Participants' pain assessed with a numeric analog score

时间窗: 24 hours after the last study visit

The visual analog score ranges from 0 to 10 where 0= no pain and 10 worst pain (5= moderate pain).

Participants' pain assessed with pictures of facial expressions

时间窗: 24 hours after the last study visit

The 6 facial pictorial expressions range from 0 to 10 where 0 is a face with a broad smile and 10 is a very sad face with tears.

Depression assessed by the Brief Mood Survey

时间窗: 24 hours after the last study visit

There are 5 questions related to feeling depressed in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'. The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain and higher scores are associated with feeling more depressed.

Anxiety assessed by the Brief Mood Survey

时间窗: 24 hours after the last study visit

There are 5 questions related to feeling anxious in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'. The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain, and higher scores are associated with feeling more anxious.

Anger assessed by the Brief Mood Survey

时间窗: 24 hours after the last study visit

There are 5 questions related to feeling angry in the Brief Mood Survey with five potential responses of- 'Not at all', 'Somewhat', 'Moderately', 'A lot', and 'Extremely'. The range of scores for each of the 5 questions is 0 to 4, with a summed total score of 0 to 20 for the domain, and higher scores are associated with feeling more angry.

次要结局

  • Emotional quality of life now(24 hours after the last study visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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