A Study on the Effectiveness of Mindfulness Meditation in Middle-Aged Hypertensive Patients with Stress
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Presumptive live event Stress
研究概览
简要总结
This study will evaluate the effectiveness of a mindfulness-based intervention (Mindfulness Meditation) in reducing blood pressure and stress levels among hypertensive individuals. A total of 260 middle-aged participants (aged 45 to 60 years), diagnosed with hypertension (systolic BP > 140 mm Hg and diastolic BP > 90 mm Hg) for at least 6 months and having a Presumptive Life Event Stress (PSLES) score greater than 200, will be enrolled in the study. This is a single blind randomized controlled trial with intervention involving two equal groups (n = 130 each) — one receiving mindfulness meditation intervention (treatment group) and the other receiving Health education talk (control group).
The control group will receive weekly health education sessions lasting 2 hours, while the study group will receive daily mindfulness meditation sessions (30 minutes per day) in addition to the same health education. Both groups will undergo the respective interventions for 10 weeks. Blood pressure and stress levels will be measured before and after the intervention. Stress will be assessed using the Perceived Stress Scale (PSS) developed by Sheldon Cohen. The study will evaluate whether the mindfulness-based intervention leads to a statistically significant reduction in both blood pressure and perceived stress in the intervention group compared to the control group.
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
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Middle aged patients (Men and Women both) with age group 45 to 60 years.
- •PSLES Score of the patients should be more than
- •Patients who are suffering with hypertension (systolic BP more than 140 mm of Hg and Diastolic BP more than 90 mm of Hg) for at least 6 months of duration will be selected.
- •Patients who refuse to take anti-hypertensives, want only lifestyle modification for BP reduction will be selected.
排除标准
- •Patients who are physically unfit to take part in the project.
- •Patient with end stage life threatening diseases.
- •Patients suffering with severe myocardial infarction, cerebral infarction, cirrhosis, uraemia.
- •Patients with hearing and vision impairment.
- •Patients who are taking anti psychotics, anti-anxiety, and antidepressive medications within last 3 months.
- •Patients with substance abuse.
- •Patients suffering from Alzheimer’s disease or any type of dementia.
结局指标
主要结局
Presumptive live event Stress
时间窗: 0 week, after completion of 5 weeks, after completion of 10 weeks
scale (PSLES) score
时间窗: 0 week, after completion of 5 weeks, after completion of 10 weeks
次要结局
- Fall in Systolic Blood Pressure (SBP)(10 weeks)
研究者
Neelanjan Sannigrahi
Gouri Devi Institute of Medical Science and Hospital