A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in heart rate variability (HRV) before, during, and after hypnosis
研究概览
简要总结
This pilot study will assess the effects of a brief laboratory-based guided imagery procedure on responses to pain in patients with sickle cell disease (SCD) and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control or with a diagnosis of sickle cell disease
- •Age 13 or older
- •African-American
- •Subject is able to provide informed signed consent
- •Subject is able to follow instructions
排除标准
- •Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity
- •Neurologic disorders affecting sensation
- •Skin abnormality/abrasion over sites of stimulus
- •Under 13 years of age
- •Unable to follow instructions
结局指标
主要结局
Change in heart rate variability (HRV) before, during, and after hypnosis
时间窗: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in galvanic skin response (GSR) before, during, and after hypnosis
时间窗: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in peripheral blood flow (pulse oximetry) before, during, and after hypnosis
时间窗: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
Change in overall respiration rate and rate of deep breathing (sighs) before, during, and after hypnosis
时间窗: Beginning 15 minutes prior to hypnosis session, continuing during 15 minutes of hypnosis, Ending 15 minutes after the hypnosis session
次要结局
- Change in pain tolerance temperature(9 minutes before beginning of hypnosis session and 4 minutes after end of hypnosis session)
- Change in pain threshold temperature(12 minutes before beginning of hypnosis session and 1 minute after end of hypnosis session)
- Change in heat pulse pain ratings(5 minutes before beginning of hypnosis session and 7 minutes after end of hypnosis session)
研究者
Lonnie Zeltzer
Distinguished Professor of Pediatrics, Anesthesiology, Psychiatry and Biobehavioral Sciences
University of California, Los Angeles