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Meditation as Complementary Treatment for Chronic Gestational Hypertension

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ClinicalTrials.gov Identifier: NCT03873194
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertension, Pregnancy-Induced Hypertension in Pregnancy Hypertension Other: Meditation Other: conventional treatment Not Applicable

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?


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
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)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meditation group
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
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.

Other: conventional treatment

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).


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

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).





Primary Outcome Measures :
  1. Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group. [ Time Frame: 8 weeks ]

    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.


  2. Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group. [ Time Frame: 8 weeks ]

    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.



Secondary Outcome Measures :
  1. Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire. [ Time Frame: 8 weeks ]

    Checking potential increases or decreases in the quality life indicator during pregnancy using the Whoqol-Bref questionnaire as a result measure.

    The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.

    This questionnaire is composed of four domains of quality of life, totaling 24 questions.

    The answers follow a Likert scale (from 1 to 5) and the domain scores for the WHOQOL-BREF were calculated by multiplying the mean of all items included within the domain by four. Potential scores for all domain scores, therefore, range from 4-20.

    Only the total quality of life score will be considered in this study. For this study, a larger score on the Whoqol-Bref demonstrates a better outcome for the group performing the meditation intervention.


  2. Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 8 weeks ]

    Checking potential increase or decreases of anxiety and depression indicators during pregnancy using the HADS Scale as a result measure.

    The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.

    The Hospital Anxiety and Depression Scale (HADS) consist of 14 questions. It was divided into an Anxiety subscale (HADS-A) consist of 07 questions and a Depression subscale (HADS-D) consist of 07 questions both containing seven intermingled items.

    Each items can be scored from zero (0) to three (3), composing a maximum score of 21 points for each sub-scale.

    • HAD-anxiety: no anxiety from 0 to 8, with anxiety ≥ 9;
    • HAD-depression: without depression from 0 to 8, with depression ≥ 9.

    For this study, a larger score on the Resilience Scale demonstrates a worst outcome for the group performing the meditation intervention.


  3. Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale. [ Time Frame: 8 weeks ]

    Checking potential increase or decreases of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress, during pregnancy using the Resilience Scale as a result measure.

    The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.

    The Resilience Scale is the scale that consist of 25 questions concerning the capacity to adapt and restore equilibrium to their lives to be rated on a 7-point scale

    The Likert scale ranged from (1) disagree to (7) agree, with higher scores reflecting higher levels of trait mindfulness.

    Possible scores range from 25 to 175 with higher scores reflecting higher resilience.

    For this study, a larger score on the Resilience Scale demonstrates a better outcome for the group performing the meditation intervention.


  4. 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) [ Time Frame: 8 weeks ]

    Checking potential increase or decreases on the presence or absence of attention to and awareness of what is occurring in the present, that differentiates meditation practitioners from others, during pregnancy using the MAAS as a result measure.

    The questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.

    The Mindful Attention Awareness Scale is the unidimensional scale that consists of 15 questions concerning attention or awareness in routine situations to be rated on a 6-point scale on how frequently or infrequently the teste experiences those situations.

    The Likert scale ranged from (1) almost always to (6) almost never, with higher scores reflecting higher levels of trait mindfulness.

    The lowest possible value to be achieved when answering this scale is 15 and the highest possible value is 90.

    For this study, a larger score on the MAAS scale demonstrates a better outcome for the group performing the meditation intervention.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873194


Contacts
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Contact: Rossana P Francisco, PhD 551126616209 rossana.francisco@hc.fm.usp.br
Contact: Fabiana A Andrade, Bachelor 551126616209 fabisgt@gmail.com

Locations
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Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403000
Contact: Rossana P Francisco, PhD    551126616209    rossana.francisco@hc.fm.usp.br   
Contact: Fabiana A Andrade, Bachelor    551126616209    fabisgt@gmail.com   
Principal Investigator: Rossana P Francisco, PhD         
Sub-Investigator: Fabiana A Andrade, Bachelor         
Sponsors and Collaborators
University of Sao Paulo General Hospital

Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03873194     History of Changes
Other Study ID Numbers: 93028218.7.0000.0068
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
systemic arterial hypertension
hypertension
hypertension, pregnancy-induced
pre-eclampsia
meditation
randomized clinical Trial

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications