An Online Randomized Controlled Trial Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Pain Experience in Adults With Recurrent and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.
详细描述
As many as 1 in 4 Australians experience chronic pain. Further, it is yet unknown the effects of the Coronavirus (COVID-19) pandemic on Australians with or at risk of chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how mindfulness meditation and common expectancy effects interact and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •At least 18 years of age
- •Recurrent pain (two or more days in the last month)
- •Chronic pain (pain most days in the last three months)
- •Able to read and understand English
排除标准
- •Not experiencing recurrent or chronic pain
- •Incomplete or invalid data (response time < 32 minutes, failing attention checks)
- •Completing the 20-minute training module in < 18 minutes or > 90 minutes
研究组 & 干预措施
Mindfulness meditation
"focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness.
干预措施: Meditation (1 x 20-minute guided audio training) (Other)
Specific sham mindfulness meditation
a training session designed to specifically match the real mindfulness training while lacking the proposed active elements of mindfulness training. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness
干预措施: Meditation (1 x 20-minute guided audio training) (Other)
General sham mindfulness meditation
a training session designed to generally match focussed-attention mindfulness meditation while maintaining greater distance from proposed mindfulness mechanisms. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness
干预措施: Meditation (1 x 20-minute guided audio training) (Other)
Book listening control
this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"
结局指标
主要结局
Pain intensity
时间窗: 40 minutes
Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)
Pain Unpleasantness
时间窗: 40 minutes
assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)
次要结局
- Pain Catastrophizing(40 minutes)