Impact of Mindfulness Meditation on Neurocognitive Functions in Gynaecological Cancer Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure includes
研究概览
简要总结
Research has demonstrated the beneficial effects of mindfulness meditation, on cognitive functioning and its association with fewer cognitive problems later in life. There is no study in literature where beneficial effect of mindfulness meditation is studied on neurocognitive deficit in gynaecologic cancer survivors. Since it is a randomized controlled trial, the results will be more impactful. Number of patients: 107 in each group
6.3. Inclusion criteria
1. Age > 18 years
2. All gynecological malignancies: carcinoma ovary, uterus, cervix
3. Completed treatment within 12 months at the time of enrollment
4. Consent for study
5. Should be able to read Hindi/English
6.4. Exclusion criteria
1. Preexisting psychiatric disorder
2. Preexisting neurocognitive disorder
3. Preexisting neurological disorder
4. History of traumatic brain injury
5. Cancer with brain metastasis
6. Individuals who are already practicing meditation
7. Not willing to participate
4.1. Primary Objective:
To determine the role of mindfulness meditation in improving neurocognitive function of gynaecological cancer survivors by assessing the neurocognitive function scores at 3 and 6 months using both subjective and objective methods.
4.2. Secondary Objective:
- To assess the level of BDNF at baseline and 6 months in intervention group
- To correlate BDNF levels with neurocognitive function scores at baseline and 6 months in intervention group
- Impact of mindfulness meditation on neurocognitive functions in various types of gynaecological cancer survivors. (Ovarian, uterine and cervical carcinomas: subgroup analysis).
Impact of mindfulness meditation on Sleep, psychological disorders like depression, stress and anxiety among gynecological cancer survivors.
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 95.00 Year(s)（—）
- 性别
- Female
入选标准
- •include: More than 18 years of age, patient who had completed treatment within 1 yr for any gynecological malignancies like carcinoma ovary, uterus, cervix and are able to read hindi or english will be included.
排除标准
- •Exclusion criteria:
- •Preexisting psychiatric disorder
- •Preexisting neurocognitive disorder
- •Preexisting neurological disorder
- •Cancer with brain metastasis
- •Individuals who are already practicing meditation
- •Not willing to participate.
结局指标
主要结局
Primary Outcome Measure includes
时间窗: at baseline, 3months, 6 months.
Change in neurocognitive function scores (reaction time and accuracy) at baseline, 3 and 6 months in intervention and control group
时间窗: at baseline, 3months, 6 months.
次要结局
- Secondary Outcome Measures:( Levels of BDNF at baseline and 6 months in intervention group)