Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

NCT03873194 | Completed

• 1 other identifier: 93028218.7.0000.0068
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pregnancy-Induced; Hypertension in Pregnancy; Hypertension

Keywords

systemic arterial hypertension; hypertension; hypertension, pregnancy-induced; pre-eclampsia; meditation; randomized clinical Trial

Outcome Measures

Primary Outcomes (2)

• Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.

  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.

  8 weeks

• Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.

  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.

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Meditation group

EXPERIMENTAL

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.

Other: Meditation; Other: conventional treatment

conventional treatment

OTHER

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

Other: conventional treatment

Interventions

Meditation OTHER

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.

Meditation group

conventional treatment OTHER

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).

Meditation group; conventional treatment

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

Location

Related Publications (21)

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MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Pre-Eclampsia

Interventions

Meditation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 13, 2019
• Study Start: April 15, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 30, 2021
• Last Updated: March 24, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)