Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
Condition: Hypertension, Pregnancy-Induced; Hypertension in Pregnancy; Hypertension
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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?

      Does meditation practice increase (or decrease) the likelihood of change in anxiety and
      depression indicators?

      Does meditation practice increase (or decrease) the likelihood of change in mindfulness
      indicators?

      Does meditation practice increase (or decrease) the likelihood of change in quality of life
      indicators?
    

Intervention name(s): Meditation; conventional treatment
Intervention type(s): Other; Other
Intervention description(s): Participants will be instructed to find a comfortable position, with a straight back, feeling the general state of their bodies (tensions, pains, heat, cold, etc.), to relax and pay attention to their own breathing, being aware of the air that gets into and out of the lungs. The women will be told that whenever their attention disperses (to another focus such as a thought, a sound, a body sensation, a judgment, etc.) they should go back to the original focus (breathing) with no feeling/judgment about the loss of focus. The practice involves focus and attention exercises and the gradual insertion of other anchors (focus points) as participants improve their skills in this practice.; Early prenatal care, when possible, is recommended as the first measure. Prenatal appointments usually take place fortnightly or weekly for hypertensive pregnant women. Extensive lab testing including specific tests for the first trimester, as well as tests for the diagnosis of superimposed pre-eclampsia and for the evaluation of lesions in target organs.
Drug treatment is only used when non-drug measures against hypertension are inefficient to decrease blood pressure levels and diastolic pressure is 90 mmHg or higher (in the first half of pregnancy) and over 100 mmHg (after 20 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The objective of this study is assess the effect of meditation as a complementary therapy in hypertensive pregnant women.
The method used will be a randomized, controlled and blinded clinical trial, where meditation is going to be offered between March 2019 and July 2020 at the Obstetrics Clinic of Hospital of Clinics, Faculty of Medicine, University of São Paulo. Patients are going to be randomly assigned to two groups: Group I, patients who are going to practice meditation and Group II, patients that will receive only the usual outpatient care.
The allocation will be performed according to CONSORT criteria and sequential within two classifications of diastolic blood pressure values.
Differences between the means of the variables (blood pressure levels and questionnaires about life quality, anxiety, resilience and mindfulness) will be compared between the groups. Values of p<0,05 will be considered significant.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: systemic arterial hypertension; hypertension; hypertension, pregnancy-induced; pre-eclampsia; meditation; randomized clinical Trial