Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
研究概览
简要总结
Pregnancy relates to arterial hypertension; it is an aggravating factor for pre-existing chronic arterial hypertension or a trigger for preeclampsia in normotensive women. The gestational hypertensive disease is managed conventionally with the pregnant woman's hospitalization and/or the use of antihypertensive medications. Nevertheless, this treatment may present some risks. The investigators seek to determine whether the intervention compared to the control can reduce the increase in blood pressure that pregnant women in the transition from the 2nd to the 3rd trimester.
详细描述
Primary research question:
Can meditation decrease the mean increase in diastolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Secondary research question:
Can meditation decrease the mean increase in systolic blood pressure in pregnant hypertensive women at the transition from the second to the third trimester of gestation?
Does meditation practice increases (or decreases) the likelihood of change in Resilience indicators?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding will be used in the following manner: after informed consent, an auxiliary researcher will randomly allocate participants to 2 research groups (Group A or Group B). After this step, the auxiliary researcher will collect data for the study and will refer the patient for the usual treatment or for the usual treatment and also meditation.
The lead researcher will not have access to the data that was collected at the beginning of the study by the auxiliary researcher before the end of the intervention step. He will analyse the results without knowing which patients were in which group (A or B). Only after statistical analysis the groups composition will be revealed.
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-existing hypertension.
- •Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
- •Prenatal follow-up in a high-risk pregnancy clinic.
- •No personal background of depression or psychiatric disorders.
- •No serious heart disease.
- •No illicit drugs and/or alcohol use.
- •Acceptance of the informed consent.
- •To follow the practice used in the study, the subjects are required to have an available phone in order to download an app which contains an audio guide for this purpose.
排除标准
- •Diagnosis of depression and psychiatric disorders during pregnancy.
- •Patients who do not return to follow-up or who want to quit the study.
- •To practice meditation.
结局指标
主要结局
Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
时间窗: 8 weeks
Diastolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
时间窗: 8 weeks
Systolic blood pressure control in pregnant women with chronic hypertension between intervention group (meditation practice) and control group, in the transition from the second to the third trimester of pregnancy, when there is a physiologic increase in arterial pressure. The systolic pressure check will be in outpatient consultation with intervals of 15 days, during. The device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine. All blood pressure checks either in the intervention group or control group will be performed on the same device.
次要结局
- Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.(8 weeks)
- Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).(8 weeks)
- Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.(8 weeks)
- Assessment on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, with Mindful Attention Awareness Scale (MAAS)(8 weeks)