Hypnosis, Meditation and Cognitive Trance on Cancer Patients: Impact on Quality of Life and Neurophysiology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in Emotional distress
研究概览
简要总结
Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •≥18 years old
- •No neurological/psychiatric disorders/history of alcohol or drug abuse
- •No current and regular practice of hypnosis, meditation or cognitive trance
- •Diagnosis of cancer (all localisations accepted except brain tumours to avoid any effect on EEG data and cognitive impairments)
- •Active treatments (surgery, chemotherapy, radiotherapy) finished for less than a year.
- •Score of at least 4/10 for one of these four symptoms at baseline: pain, fatigue, sleep difficulties, emotional distress.
排除标准
- •< 18 year old
- •No cancer diagnosis
- •Neurological or psychiatric disorder
- •Brain tumour ou other tumour with brain metastases
- •Active treatments still ongoing or finished for more than a year
- •No baseline symptom at 4/10
结局指标
主要结局
Change in Emotional distress
时间窗: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress
Change in Fatigue
时间窗: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)
Change in Pain
时间窗: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)
Change in Sleep difficulties
时间窗: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.
Change in Perceived cognitive difficulties
时间窗: Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4)
Assessed with a questionnaire (FACT-Cog), investigation 4 dimensions (perceived cognitive impairments, score range 0-72, higher score indicating less impairments ; impact of cognitive impairments on quality of life, score range 0-16, with higher scoe indicating less impact ; Comments from others, score range 0-16 with higher score indicating less comments ; perceived cognitive abilities, score range 0-28, with higher score indicating more cognitive abilities)
次要结局
- Fantasy Proneness (imaginative experiences)(Assessed before the intervention (T0))
- Change in Empowerment(Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in Characteristics of the intense memory described above(Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in body movements(Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.)
- Change in Psychological flexibility(Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Personnality characteristics(Assessed before the intervention (T0))
- Expectations and motivation to participate in the chosen intervention(Assessed before the intervention (T0))
- Change in the characteristics of a free recall of an intense hypnosis/cognitive trance/meditation episode (or an intense autobiographical episode for the participants in the control group)(Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in presence during the intense memory described above(Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in the quality of the relationship with the therapist who animated the group sessions(Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in Emotion regulation(Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in Mystical characteristics of the intense memory described above(Assessed immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Change in Mental Adjustment to Cancer(Assessed before the intervention (T0), immediately after the intervention (T1), and at 3- and 12-month follow-up (T3 and T4))
- Personal definition of hypnosis/cognitive trance/meditation(Assessed before the intervention (T0))
- Change in body temperature(Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.)
- Change in cerebral activity(Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.)
- Change in heart rate(Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.)
- Change in respiration(Resting state : Assessed before the intervention (T0), immediately after the intervention (T1), and at 12-month follow-up (T4). During hypnosis, trance or meditation : T1, T4.)
研究者
Audrey Vanhaudenhuyse
PhD in Medical Sciences
University of Liege