Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

University of Sao Paulo General Hospital

Status: Completed

Conditions: Hypertension; Hypertension, Pregnancy-Induced; Hypertension in Pregnancy

Treatments: Other: Meditation; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03873194

93028218.7.0000.0068

Details and patient eligibility

About

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.

Full 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?

Enrollment: 47 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pre-existing hypertension.
2. Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.
3. Prenatal follow-up in a high-risk pregnancy clinic.
4. No personal background of depression or psychiatric disorders.
5. No serious heart disease.
6. No illicit drugs and/or alcohol use.
7. Acceptance of the informed consent.
8. 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.

Exclusion criteria

1. Diagnosis of depression and psychiatric disorders during pregnancy.
2. Patients who do not return to follow-up or who want to quit the study.
3. To practice meditation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

Meditation group

Experimental group

Description:

Patients who are going to practice meditation and will receive only the usual outpatient care, with the aim of observing reduction of systemic blood pressure in this period.

Treatment:

Other: Meditation

Other: conventional treatment

conventional treatment

Other group

Description:

Patients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period.

Treatment:

Other: conventional treatment