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临床试验/NCT04287452
NCT04287452撤回不适用

Canine-Assisted ANxiety Reduction IN Emergency Care IV (CANINE IV)

Indiana University2 个研究点 分布在 1 个国家开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in salivary cortisol in ED patients with chronic pain

研究概览

简要总结

Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can;

  • decrease reported anxiety levels in emergency department (ED) patients,
  • decrease salivary cortisol in ED patients,
  • decrease total morphine equivalent dosing in the emergency department or at discharge and/or,
  • decrease reported stress levels in emergency department providers caring for participating patients

when compared to usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Age 18-89 years
  • Chronic pain, defined as pain on most days for >6 weeks
  • Triage pain score >6 out of 10
  • Age 18-89 years
  • Currently experience crisis, including suicidality, or
  • Meet the standard of a provider assessment of "severe stress" defined by their identification that the patient meets a score of greater than six on the FACES stress scale
  • Faculty, residents, advanced practitioners, and nurses who work in the ED and identify themselves as being the nurse or physician of record for the enrolled patients.
  • Therapy Dog Handlers
  • Handler of a certified therapy dog and volunteer of Eskenazi's Therapy Dog Program

排除标准

  • Violent behavior
  • Overt intoxication
  • Non-English speaking
  • Any reported prior fear or adverse reaction to dogs
  • Any reported prior fear or adverse reaction to dogs
  • Therapy Dog Handlers

结局指标

主要结局

Change in salivary cortisol in ED patients with chronic pain

时间窗: Baseline and T1 (~45 minutes after baseline)

Change in salivary cortisol levels in emergency department patients between baseline and T1

Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis

时间窗: Date of enrollment until emergency department discharge, up to 72 hours

Number of narcotic, sedative and/or neuroleptic doses administered in ED patients with emotional crisis

Change in reported stress levels in ED patients with chronic pain using Wong-Baker FACES Scale (10 = worst)

时间窗: Baseline and T1 (~45 minutes after baseline)

Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1

Morphine equivalent narcotic administration in emergency department patients with chronic pain

时间窗: Date of enrollment until emergency department discharge, up to 72 hours

Total morphine equivalent narcotic administration while in the emergency department or as a discharge prescription will be recorded for enrolled patients.

Change in salivary cortisol in ED patients with emotional crisis

时间窗: Baseline and T1 (~45 minutes after baseline)

Change in salivary cortisol levels in emergency department patients between baseline and T1

Change in reported stress levels in ED patients with emotional crisis using Wong-Baker FACES Scale (10 = worst)

时间窗: Baseline and T1 (~45 minutes after baseline)

Change in self reported stress levels of emergency department patients using a Wong-Baker FACES Scale for anxiety between baseline and T1

次要结局

  • Change in salivary cortisol levels in emergency department patients(Baseline and T1 (~45 minutes after baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Pettit

Assistant Professor of Emergency Medicine

Indiana University

研究点 (2)

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