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临床试验/NCT03407937
NCT03407937已完成不适用

The Role of the Endocannabinoids During the Analgesia Caused by Hypnosis and Meditation

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年11月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Change from baseline concentration of endocannabinoids at the end of the intervention

研究概览

简要总结

Introduction: Many interventions such as hypnosis, mindfulness meditation, conditioned pain modulation and placebos have been shown to effectively reduce pain both in the laboratory and in clinical settings. However, little is known about their neurophysiological mechanisms of action. Analgesia induced by these techniques is thought to be based on opioidergic and non-opioidergic mechanisms (potentially endocannabinoid mechanisms). Objective: Our main objective is to evaluate the effect of hypnosis, meditation, conditioned pain modulation and placebo on blood concentrations of endocannabinoids (anandamide, 2-arachidonylglycerol, N-palmitoyl-ethanolamine, N-oleoylethanolamide), endogenous opioids (β-endorphins, met / leu-enkephalins, and dynorphins) and norepinephrine in healthy adults. Methods: This study is based on a single-group pre-experimental research design in which two experimental sessions including hypnosis or meditation, conditioned pain modulation and placebo interventions will be completed by all participants. In order to have a better description of the sociodemographic and clinical characteristics of the sample, information will be collected by questionnaires or tests filled by participants at baseline, including: age, sex, language, culture, religion, salary, menstrual cycle of women, medication (if any), mood, anxiety, pain catastrophizing, mindfulness, hypnotic susceptibility, and DNA information. Outcome measures will be collected before, during and after each intervention. The primary outcome is plasma concentrations of endocannabinoids. Secondary measurements include plasma concentrations of endogenous opioids and norepinephrine; change in pain intensity during the thermal noxious stimuli; and autonomic nervous system variability (as measured by heart rate variability). Anticipated results: The investigators expect a positive relationship between the change in pain intensity (analgesia) induced by the interventions (hypnosis, meditation, conditioned pain modulation, and placebo) and the change (increase) in plasma concentrations of endocannabinoids, opioids, and norepinephrine in healthy adults. It is also believed that the interventions will influence heart rate variability. Moreover, it is expected that there will be a relationship between the efficiency of the analgesic intervention and some gene polymorphisms associated to pain modulation and endocannabinoids, opioids or norepinephrine in healthy individuals.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being an healthy adult aged 18-45 years old with no prior experience of hypnosis.

排除标准

  • Having difficulty understanding french language
  • Having a vulnerability to dissociative or psychotic episodes
  • Having a diagnosed medical condition or diagnosis of chronic pain leading to kidney, liver, dermatological, respiratory, hematological, immunological, cardiovascular, inflammatory, rheumatologic, endocrine, metabolic, neurological or psychiatric pathologies
  • Being pregnant or breast-feeding
  • Having a body mass index over 40
  • Using medication, recreational drugs or other agents that affect the central nervous system or the perception of pain (e.g., analgesics, opioids, antiepileptics, muscle relaxers)

研究组 & 干预措施

Intervention

Other

Receiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.

干预措施: Hypnosis (Behavioral)

Intervention

Other

Receiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.

干预措施: Meditation (Behavioral)

Intervention

Other

Receiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.

干预措施: Conditioned pain modulation (Other)

Intervention

Other

Receiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

Change from baseline concentration of endocannabinoids at the end of the intervention

时间窗: Immediately before and after each intervention

Concentrations (ng/ml) of endocannabinoids (anandamide, 2-arachidonylglycerol, N-palmitoyl-ethanolamine, N-oleoylethanolamide) will be measured in the plasma of participants

次要结局

  • Measure of the autonomic nervous system(Immediately before, during and immediately after each intervention)
  • Quantitative aspect of pain(Immediately before and after each intervention)
  • DNA in salivary sample(Immediately after all the interventions have been completed, which will be during the second session after the pill has been ingested)
  • Change from baseline concentrations of norepinephrine at the end of the intervention(Immediately before and after each intervention)
  • Change from baseline concentrations of opioids at the end of the intervention(Immediately before and after each intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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