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CompletedNCT03873194

Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
Female
Age
21 Years – 50 Years
Healthy volunteers
Not accepted

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?

Conditions

Interventions

TypeNameDescription
OTHERMeditationParticipants 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.
OTHERconventional treatmentEarly 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).

Timeline

Start date
2019-04-15
Primary completion
2021-12-15
Completion
2021-12-30
First posted
2019-03-13
Last updated
2022-03-24

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03873194. Inclusion in this directory is not an endorsement.