Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
NCT ID: NCT03873194
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2019-04-15
2021-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
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.
Study Groups
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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.
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.
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
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
2. Patients who do not return to follow-up or who want to quit the study.
3. To practice meditation.
21 Years
50 Years
FEMALE
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Countries
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References
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Bernstein PS, Martin JN Jr, Barton JR, Shields LE, Druzin ML, Scavone BM, Frost J, Morton CH, Ruhl C, Slager J, Tsigas EZ, Jaffer S, Menard MK. Consensus Bundle on Severe Hypertension During Pregnancy and the Postpartum Period. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):776-787. doi: 10.1016/j.jogn.2017.05.003. Epub 2017 Jul 11.
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Mulder EJ, Robles de Medina PG, Huizink AC, Van den Bergh BR, Buitelaar JK, Visser GH. Prenatal maternal stress: effects on pregnancy and the (unborn) child. Early Hum Dev. 2002 Dec;70(1-2):3-14. doi: 10.1016/s0378-3782(02)00075-0.
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Beddoe AE, Paul Yang CP, Kennedy HP, Weiss SJ, Lee KA. The effects of mindfulness-based yoga during pregnancy on maternal psychological and physical distress. J Obstet Gynecol Neonatal Nurs. 2009 May-Jun;38(3):310-9. doi: 10.1111/j.1552-6909.2009.01023.x.
van den Heuvel MI, Donkers FC, Winkler I, Otte RA, Van den Bergh BR. Maternal mindfulness and anxiety during pregnancy affect infants' neural responses to sounds. Soc Cogn Affect Neurosci. 2015 Mar;10(3):453-60. doi: 10.1093/scan/nsu075. Epub 2014 Jun 12.
Narendran S, Nagarathna R, Narendran V, Gunasheela S, Nagendra HR. Efficacy of yoga on pregnancy outcome. J Altern Complement Med. 2005 Apr;11(2):237-44. doi: 10.1089/acm.2005.11.237.
Narendran S, Nagarathna R, Gunasheela S, Nagendra HR. Efficacy of yoga in pregnant women with abnormal Doppler study of umbilical and uterine arteries. J Indian Med Assoc. 2005 Jan;103(1):12-4, 16-7.
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Other Identifiers
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93028218.7.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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