A Randomised Controlled Trial to assess the effectiveness of Optimised Nutritional Education on Headache Frequency and Disability among Migraine patients attending the Neurosciences OPD at AIIMS, New Delhi.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Proportion of patient with 30% reduction in headache frequency by Headache Diary.
研究概览
简要总结
A Randomised Controlled Trial to assess the effectiveness of Optimised Nutritional Education on Headache Frequency and Disability among Migraine patients attending the Neurosciences OPD at AIIMS, New Delhi
Headache disorders are among the most common disorders of the nervous system, ranking third (after stroke and dementia) in contributing to the overall neurological disease burden, as measured by age-standardized disability-adjusted life years (DALYs) in 2019.Migraine is a complex neurological illness with a genetic component, characterized by episodes of moderate-to-severe headaches, typically unilateral, and often accompanied by nausea, photophobia, and phonophobia.
According to the Global Burden of Disease study, migraines account for 4.9% of all years lived with disability, To evaluate the effectiveness of optimised nutritional education on headache frequency and disability among migraine patients attending the Neuroscience Outpatient Department(OPD) at AIIMS, New Delhi. Research approach : Quantitative approach, Research design : Randomized Controlled Trial (RCT) Trial Design: A parallel-group randomized controlled trial with a 1:1 allocation ratio. The sample size is calculated to detect a 30% reduction in primary outcomes (headache frequency and disability) with 90% power and a 5% significance level. Intervention Group:
Structured Optimised Nutritional Education including:-Written dietary plans, Strategies for incorporating migraine-friendly foods., Identification of dietary triggers.
There will be significant difference in headache frequency after optimised nutritional education in intervention group in comparison with control group at the 0.05 level of significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with more than 18 years diagnosed with episodic migraine.
- •Participants having 4 migraine attacks in last 1 month.
- •Willingness to adhere to the dietary education intervention.
- •Those who understand Hindi or English.
排除标准
- •Patient with chronic headache disorder.
- •Individual currently on a restrictive diet.
- •Presence of other Neurological Disorders or any Psychiatric condition.
- •Patient with significant co-morbid conditions (eg., Cancer, Diabetes, Chronic Renal insufficiency).
结局指标
主要结局
1. Proportion of patient with 30% reduction in headache frequency by Headache Diary.
时间窗: 1. Migraine frequency | Baseline at day 1 | Follow up at day 30 | Follow up at day 60 | Follow up at day 90 | 2. Migraine Disability | Baseline at day 1 | Followup at day 90
2. Proportion of patient with 30% reduction in disability scores measured by MIDAS, HIT-6.
时间窗: 1. Migraine frequency | Baseline at day 1 | Follow up at day 30 | Follow up at day 60 | Follow up at day 90 | 2. Migraine Disability | Baseline at day 1 | Followup at day 90
次要结局
- 3. To assess the adherence of optimised nutritional education among migraine patients at Neuroscience OPD, AIIMS New Delhi.
研究者
Tamanna Kumari
All India Institute of Medical Sciences