Shared Meditation Involving People With Cancer, Carers and Third Parties: Any Added Value Compared With Meditation Conducted With Patients? IMPLIC 2, a Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
研究概览
简要总结
Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated.
This project is based on the hypothesis that there could be a benefit in meditating together.
详细描述
The main aims of this randomised study are to improve well-being, strengthen links between carers, patients and third parties and raise awareness of the importance of living together better by offering meditation as a shared activity. The expected benefits of meditation therefore primarily concern the relief of psychological suffering. Promoting better understanding between carers and patients, and looking at oneself and others in a different way are experiences that aim to encourage exchanges and interactions between populations. For cancer patients (the target population), pain and other symptoms associated with the disease and its treatment will be better managed.
The pain experienced by carers, which is essentially linked to professional overwork and contact with illness, will be considered and managed through meditation, resulting in benefits for carers and their way of interacting with their patients.
The expected collective benefit is to develop and better live together our interdependence and humanity, by recognising suffering as a shared characteristic, despite our specific problems (as patients, carers or third parties).
The overall aim is to alleviate suffering, which is an integral part of the human experience, by cultivating our common humanity.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Criteria for all participants (patients, carers and third parties)
- •Participant with no current or previous experience of regular or intensive meditation or comparable practice. Practice is considered regular and/or intensive if :
- •it occurs more than one day a week for more than 6 consecutive months over the last 10 years,
- •and/or more than 5 consecutive days of intensive practice (course or retreat) in the last 10 years,
- •and/or more than 25 consecutive days of retreat (cumulative) in the last 10 years.
- •Patient-specific criteria (target population) - Cancer patients (regardless of location)
- •Specific criteria for carers
- •- All medical and/or paramedical care staff at the Centre François Baclesse in contact with patients (doctors, nurses, nursing assistants, radiotherapy technicians, etc.)
- •Specific criteria for third parties- Any volunteer not belonging to the two categories above
排除标准
- •Participants with significant vulnerability factors such as alcohol or drug dependence, severe depression, severe social anxiety, recent bereavement, etc.)
- •Participant unable to undergo trial monitoring for geographical, social or psychopathological reasons
结局指标
主要结局
To assess the possible added value for patients (target population) of a meditation programme shared between patients, carers and third parties, compared with the same meditation programme conducted solely for patients.
时间窗: measured at the end of the meditation programme (after the 12 weekly sessions) compared with the measurement at inclusion
Changes in self-efficacy scores according to the Generalized Self Efficacy Scale \[min 10; max 40\]
次要结局
未报告次要终点