Clinical trial NCT03873194: Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
Official title: Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Hypertension in Pregnancy
Hypertension
Keywords: systemic arterial hypertension
hypertension
hypertension, pregnancy-induced
pre-eclampsia
meditation
randomized clinical Trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 47
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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?

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.
timeFrame: 8 weeks
measure: Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.
timeFrame: 8 weeks
Secondary outcomes:
measure: Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.
timeFrame: 8 weeks
measure: Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).
timeFrame: 8 weeks
measure: Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.
timeFrame: 8 weeks
measure: 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)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
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