Hypnosis and Meditation for Pain Management in Veterans: Efficacy and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 10
- 主要终点
- Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)
研究概览
简要总结
Chronic pain is a significant problem for many Veterans, including new Veterans returning from Iraq and Afghanistan. It is also associated with a number of other significant problems, such as post-traumatic stress disorder and sleep problems. All of these can have significant negative effects of the quality of life of Veterans
Three different types of treatment that have been used to treat chronic pain in the general population include self-hypnosis, education about chronic pain, and teaching individuals how to be more mindful. The purpose of this study is to see if these three treatments can help decrease pain in Veterans. Additionally, the researchers want to determine if each of these treatments can help reduce the negative consequences associated with pain, such as changes in mood, sleep, and enjoyment of life.
Different types of treatment that include self-hypnosis, education about chronic pain, and learning skills on how to change how a person perceives his/her pain have been used to treat chronic pain the general population.
The purpose of this study of this study is to see if these different treatments can help decrease pain and improve quality of life in Veterans with chronic pain, and determine how and why these treatments are effective. A subject must have a Veteran status, have chronic pain, speak English and be at least 18 years old to participate.
Sleep Sub-Study
Chronic pain and sleep problems are common among Veterans. Study researchers believe the treatment interventions provided as part of the main study will help improve pain and sleep. However, the main study does not include a "real time" measurement of sleep nor does it include any specific strategies for examining the relationship between sleep and pain.
Previous research has shown that adequate sleep has been linked to improvements in pain reports. Adversely, sleep deprivation has been found to increase pain perception since it decreases a person's ability to disengage from pain. Therefore, the purpose of this sub-study is to measure sleep in order to learn more about how it interacts with chronic pain.
All of the subjects in this sub-study will be Veterans recruited from VA Puget Sound who experience moderate-to-severe chronic pain on a regular basis and who have enrolled in the main study. Study investigators will enroll up to 135 subjects into the sub-study.
详细描述
Cognitive Assessment
Following enrollment, research staff will administer a battery of five neuropsychological measures assessing memory, information processing, and executive functioning. These measures take approximately 20-30 minutes to complete.
Hypnotic and Relaxation Exercise
A research staff member will administer in person the Modified Stanford Hypnotic Clinical Scale (SHCS) to assess hypnotizability for all participants following enrollment but prior to randomization. This measure takes approximately 15-20 minutes to complete.
Baseline Data and Demographic Form
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •Veteran eligible for services through Veteran Health Affairs;
- •experience moderate to severe chronic pain on a regular basis; and
- •able to read, speak and understand English.
排除标准
- •severe cognitive impairment;
- •current or history of psychiatric or behavioral issues that require immediate attention and/or prevent the subject from participating effectively in the study;
- •reported use of a high dose of an opioid(s).
结局指标
主要结局
Change From Pre-Treatment in Average Pain Intensity on a 0-10 Numerical Rating Scale Immediately Following End of Treatment (Post-Treatment)
时间窗: Change in Average Pain Intensity from Pre-Treatment to Immediately Following End of Approximately Eight Weeks of Treatment (Post-Treatment)
An average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity was obtained over a period of one week during each assessment period, pre-treatment and post-treatment. Range: 0-10, 0='no pain' and 10 ='pain as bad as you can imagine' The difference between the two average scores from the different assessment periods (pre-treatment and post-treatment) was computed by subtracting the pre-treatment score from the post-treatment score, resulting in a change score. A negative value denotes a decrease in pain intensity between the two assessment periods, whereas a positive value denotes an increase.
次要结局
未报告次要终点
研究者
Mark Jensen
Professor, Rehabilitation Medicine
University of Washington