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临床试验/NCT06232382
NCT06232382尚未招募不适用

A Comparison of Hypnosis and Mindfulness on Reducing Pain in Chronic Pain Patients: A Randomized Controlled Study

Siriraj Hospital0 个研究点目标入组 165 人开始时间: 2024年2月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarocha Watatham

Co-investigator, Pain Fellow

Siriraj Hospital

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