Self-induced Cognitive Trance to Improve Quality of Life of Patients With Chronic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Pain intensity
研究概览
简要总结
The need to find complementary approaches, based on a holistic perspective of the human being, takes on its full meaning in a political context that recommends efficient health programs. Self-induced cognitive trance is one of these complementary approaches, which induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether learning self-induced cognitive trance can improve the quality of life of people with chronic pain. Participants will participate in two times two days workshop aiming at learning how to self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12 months afer the last workshop will be caried out were outomes will be assessed. Furthmore, questionnaires related to the phenomenology of self-induced cognitive trance will be adeministrered. Investigators also proceeded to interveiwes after the second workshop to gather qualitative information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •French speacking
- •Chronic pain
- •On stable pharmacological treatment over the last four months
排除标准
- •Psychiatric disorders,
- •drug addiction
- •alcoholism
结局指标
主要结局
Pain intensity
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)
Fatigue intensity
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)
Quality of life
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
The Short From Health Survey assesses overall quality of life. It comprises 36 items subdivided into 9 subscales: physical functioning, limitations resulting from physical health, limitations resulting from emotional health, vitality (energy/fatigue), emotional well-being, social functioning, pain, general state of health and, finally, changes in state of health. Each of these scales is weighted by a score ranging from 0 to 100. The first 8 dimensions of the SF-36 are grouped into 2 synthetic scores. A physical score (PCS) groups the 8 dimensions according to a weighting that favors the physical component, while the mental score (MCS) summarizes the mental component of the dimension scores. The higher the scores, the better the mental and physical health. The final item assesses perceived change in health status.
Anxiety
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a "normal" state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.
Depression
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a "normal" state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.
Attitudes towards pain
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
The Survey of Pain Attitude-35. It is composed of 7 subscales: perceived disability measures the belief that disability is caused by pain; pain-injury link assesses the belief that pain is a physical injury; medication measures the belief that medication is the only remedy, solicitude measures the belief that those around patients should assist them in their painful experience, expectation of cure measures the belief that doctors are responsible for reducing their pain, perceived control assesses the feeling of perceived control, and finally, emotion measures the feeling that emotions have an impact on pain. Scores are specific to each scale. The higher the score, the more patients hold this belief.
Global Impression of change
时间窗: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
Global Impression of change assesses patients' beliefs about the effectiveness of their treatment on their disease. It's a simple scale that goes up to 7 points, equivalent to the best possible improvement.
次要结局
- Positive affect(Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up)
- Mystical Experience(Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up)
- Experience with trance(Immediately after the second workshop)
- Negative affect(Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up)
- Ego-Dissolution(Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up)
- Phenomenology of trance(Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up)
研究者
Audrey Vanhaudenhuyse
Head
University of Liege