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临床试验/NCT02100163
NCT02100163已完成不适用

Controling Pain After Orthopedic Trauma

National Institute of General Medical Sciences (NIGMS)2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
211
试验地点
2
主要终点
Graphic Rating Scale (GRS) pain and anxiety Questionnaire

研究概览

简要总结

The treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. The goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. This proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. The findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. Reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

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

入选标准

  • Compliant and able to complete questionnaires
  • English speaking
  • Hospitalization for trauma orthopedic injuries
  • No history of psychiatric disorder
  • Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
  • Able to communicate verbally
  • 18 years of age or older

排除标准

  • Not capable of filling out study measures
  • Evidence of a traumatic brain injury or any other
  • Cognitive deficits that would impact decisional capacity to consent for the
  • study or complete measures
  • History of psychiatric disorder as evidenced in the RN and MD admission notes
  • Unable to communicate verbally
  • Extreme susceptibility to motion sickness
  • Seizure history
  • Non-English speaking
  • In isolation for infections such as Clostridium difficile

研究组 & 干预措施

Virtual Reality Hypnosis

Experimental

The patient receives VRH daily.

干预措施: Virtual Reality Hypnosis (Behavioral)

Audio Hypnosis

Experimental

The patient receives Audio Hypnosis daily.

干预措施: Audio Hypnosis (Behavioral)

Standard Treatment

Experimental

The patient receives the standard treatment. This is a control group and there are no interventions.

干预措施: Standard treatment (Other)

结局指标

主要结局

Graphic Rating Scale (GRS) pain and anxiety Questionnaire

时间窗: up to 10 days

Measures pain and anxiety

次要结局

  • Tellegen Absorption Scale(1 day (Once in the hospital))

研究者

发起方
National Institute of General Medical Sciences (NIGMS)
申办方类型
Nih
责任方
Principal Investigator
主要研究者

David R. Patterson

Professor

National Institute of General Medical Sciences (NIGMS)

研究点 (2)

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