Assessment of the effect of guided mindfulness meditation on sensory hypersensitivity and cognitive function in patients with migraine, irritable bowel syndrome, and fibromyalgia: a randomized controlled study with extended follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This is a prospective randomized controlled study designed to evaluate the effect of guided mindfulness meditation on sensory hypersensitivity and cognitive function in patients diagnosed with migraine with comorbid irritable bowel syndrome and fibromyalgia. Eligible participants aged 18 to 80 years will be randomly allocated to either a guided mindfulness meditation intervention group or a control group receiving standard care. The intervention group will undergo structured mindfulness meditation sessions for a predefined duration, while the control group will continue routine clinical management. Outcome measures will include changes in sensory hypersensitivity scores and cognitive function assessed at baseline and predefined follow up intervals. Secondary outcomes will include headache related disability and quality of life measures. The study aims to assess the feasibility and effectiveness of mindfulness based intervention as an adjunctive non pharmacological therapy in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults aged eighteen to fifty five years diagnosed with migraine as per International Classification of Headache Disorders criteria, with comorbid irritable bowel syndrome and fibromyalgia, willing to provide informed consent and comply with study procedures.
排除标准
- •Secondary headache disorders, severe psychiatric illness, cognitive impairment interfering with assessment, pregnancy or lactation, concurrent participation in another interventional study, or inability to comply with the intervention protocol.
研究者
Dr Sujata Roshan
Govind Ballabh Pant Hospital, Delhi
