Controling Pain After Orthopedic Trauma
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
- 否
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
The patient receives VRH daily.
干预措施: Virtual Reality Hypnosis (Behavioral)
Audio Hypnosis
The patient receives Audio Hypnosis daily.
干预措施: Audio Hypnosis (Behavioral)
Standard Treatment
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
David R. Patterson
Professor
National Institute of General Medical Sciences (NIGMS)
