A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 165
- 主要终点
- Change in pain intensity
研究概览
简要总结
The goal of this randomized controlled study is to evaluate the efficacy of an audio session of hypnosis and mindfulness meditation for providing immediate pain relief in individuals with chronic pain from Thailand. The main question[s] it aims to answer are:
• What effects do hypnosis and mindfulness meditation on reducing pain in chronic pain patients? Participants will
- Be randomly assigned to one of the three conditions in 20 minutes: Audio hypnosis, Audio mindfulness, A control condition
- Be blind to the study hypotheses.
- To keep the experimenter blind, the participants will not reveal what they hear in the audio.
- Pain intensity will be assessed both at pre- and post-session.
- Secondary outcomes will be assessed at pre- and post-session by the questionnaires.
- Post-session quality of sleep will be assessed by telephone interview 1 day after the session.
Primary outcome: Current pain intensity (using a 0 - 10 numerical rating scale) Secondary outcome
- Anxiety at pre and post-session using a 0-10 numerical rating scale
- 0-10 numerical rating scale assessing average, worst, and least pain intensity experienced during the sessions
- 1-5 categorical scale of treatment satisfaction assessed at post-treatment
- Quality of sleep using the Thai version of the Patient-Reported Outcomes Measurement Information System-29 (T-PROMIS-29) sleep disturbance section (4 items) at pre-session and 1 day after a session (by telephone interview)
- Duration of benefit The proposed measures of these variables have all been used successfully in prior clinical trials in samples of individuals with pain from Thailand.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
- Participants will be blind to the study hypotheses.
- To keep the experimenter blind, the participants will not reveal what they hear in the audios.
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
- •Being ≥ 18 years old
- •Having chronic, non cancer pain (i.e., reporting bothersome pain for at least 50% of the days during the last three months)
- •Nociceptive, neuropathic, nociplastic pain characteristic
- •Endorsing having current pain intensity of ≥ 4 on a 0 to 10 Numerical Rating Scale
- •Being able to read, speak, and understand Thai
排除标准
- •Having significant hearing loss that would interfere with being able to hear the study audio
- •Having significant cognitive dysfunction, physical disability, or severe mood disturbance (e.g., significant anger or high lability) that would interfere with being able to participate in the study procedures
- •Cancer-related pain or cancer patients
结局指标
主要结局
Change in pain intensity
时间窗: Baseline (immediately prior to intervention), 5 minutes after the intervention
Current pain intensity will be assessed using a 0 - 10 numerical rating scale with 0 = "No pain" and 10 = "Pain as bad as it could be."
次要结局
- Change in anxiety(Baseline (immediately prior to intervention), 5 minutes after the intervention)
- Average, worst, and least pain intensity experienced during the sessions(5 minutes after the intervention)
- Satisfaction(5 minutes after intervention)
- Change in quality of sleep(Baseline (immediately prior to intervention) and 24 hours after session (by telephone interview))
研究者
Sarocha Watatham
Co-investigator, Pain Fellow
Siriraj Hospital
