An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Pain unpleasantness
研究概览
简要总结
This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.
详细描述
Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.
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)
盲法说明
The experimenter will remain blind to participant condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older;
- •Able to read, speak and understand English.
排除标准
- •Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
- •Experience of recurrent fainting spells;
- •Report of a chronic pain condition;
- •Use of alcohol and/or pain medication in the last 24-hours;
- •Currently receiving psychiatric care;
- •Problems with allergic skin reactions or excessive bruising;
- •Previous participation in a cold pressor experiment.
- •All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.
- •These exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.
结局指标
主要结局
Pain unpleasantness
时间窗: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Numerical rating scale in response to exposure to a cold pressor task.
Pain intensity
时间窗: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Numerical rating scale in response to exposure to a cold pressor task.
Pain tolerance
时间窗: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.
次要结局
- Mechanism: Attention Network Task(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Mindfulness(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Physiological response to pain stimulus(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Mind Wandering Task(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Pain appraisals(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Hypnotizability(Baseline score at Experimental Session 1 (Day 1))
- Mechanism: Pain catastrophizing(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Pain-Related Cognitive Processes(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
- Mechanism: Pre-treatment expectancies(Baseline score at Experimental Session 1 (Day 1))