Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in peripheral blood flow before and during the intervention
研究概览
简要总结
The purpose of this study is to test the effects of a laboratory-based hypnosis session compared to an attention control condition on peripheral blood flow, autonomic stress responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and examine how perceived disease-related stigma may affect these responses.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of sickle cell disease
- •Age 12-21 years old
- •Fluent in English (the intervention will be delivered in English)
- •Participant is cognitively able to provide informed signed consent or assent
- •Participant is cognitively able to follow instructions
排除标准
- •Under 12 years of age or over 21 years of age
- •Not fluent in English
- •Pain medication prescription has changed or if they have been hospitalized for a vaso-occlusive episode within 30 days of study participation.
- •Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation, skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic heart disease) or cognitive impairment that may affect data integrity or the ability to complete study procedures.
结局指标
主要结局
Change in peripheral blood flow before and during the intervention
时间窗: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
次要结局
- Change in heat pulse pain intensity ratings(5 minutes before the start of the intervention and 21 minutes after the start of the intervention.)
- Change in pain tolerance temperature(9 minutes before the start of the intervention and 18 minutes after the start of the intervention.)
- Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma(12 minutes before the start of the intervention and 15 minutes after the start of the intervention)
- Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma(5 minutes before the start of the intervention and 21 minutes after the start of the intervention.)
- Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma(15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention)
- Change in pain threshold temperature(12 minutes before the start of the intervention and 15 minutes after the start of the intervention.)
- Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma(9 minutes before the start of the intervention and 18 minutes after the start of the intervention.)
研究者
Sarah R. Martin
Principal Investigator
University of California, Los Angeles