Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT03873194
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nThe 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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The objective of this study is assess the effect of meditation as a complementary therapy in hypertensive pregnant women.\n\nThe 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.\n\nThe allocation will be performed according to CONSORT criteria and sequential within two classifications of diastolic blood pressure values.\n\nDifferences 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Comparison the means of diastolic blood pressure of pregnant women's between intervention group and control group.", 'timeFrame': '8 weeks', 'description': '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.\n\nThe diastolic pressure check will be in outpatient consultation with intervals of 15 days, during 8 weeks.\n\nThe device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine.\n\nAll blood pressure checks either in the intervention group or control group will be performed on the same device.'}, {'measure': "Comparison the means of systolic blood pressure of pregnant women's between intervention group and control group.", 'timeFrame': '8 weeks', 'description': '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.\n\nThe systolic pressure check will be in outpatient consultation with intervals of 15 days, during.\n\nThe device used for checking the pressure will be the GAMMA XXL LF of Heine General Medicine.\n\nAll blood pressure checks either in the intervention group or control group will be performed on the same device.'}], 'secondaryOutcomes': [{'measure': 'Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.', 'timeFrame': '8 weeks', 'description': 'Checking potential increases or decreases in the quality life indicator during pregnancy using the Whoqol-Bref questionnaire as a result measure.\n\nThe questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.\n\nThis questionnaire is composed of four domains of quality of life, totaling 24 questions.\n\nThe 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.\n\nOnly 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.'}, {'measure': 'Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).', 'timeFrame': '8 weeks', 'description': 'Checking potential increase or decreases of anxiety and depression indicators during pregnancy using the HADS Scale as a result measure.\n\nThe questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.\n\nThe 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.\n\nEach items can be scored from zero (0) to three (3), composing a maximum score of 21 points for each sub-scale.\n\n* HAD-anxiety: no anxiety from 0 to 8, with anxiety ≥ 9;\n* HAD-depression: without depression from 0 to 8, with depression ≥ 9.\n\nFor this study, a larger score on the Resilience Scale demonstrates a worst outcome for the group performing the meditation intervention.'}, {'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', 'description': '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.\n\nThe questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.\n\nThe 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\n\nThe Likert scale ranged from (1) disagree to (7) agree, with higher scores reflecting higher levels of trait mindfulness.\n\nPossible scores range from 25 to 175 with higher scores reflecting higher resilience.\n\nFor this study, a larger score on the Resilience Scale demonstrates a better outcome for the group performing the meditation intervention.'}, {'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', 'description': '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.\n\nThe questionnaire will be applied at the entrance of the participant in the study and at the end of the 8 weeks.\n\nThe 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.\n\nThe Likert scale ranged from (1) almost always to (6) almost never, with higher scores reflecting higher levels of trait mindfulness.\n\nThe lowest possible value to be achieved when answering this scale is 15 and the highest possible value is 90.\n\nFor this study, a larger score on the MAAS scale demonstrates a better outcome for the group performing the meditation intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic arterial hypertension', 'hypertension', 'hypertension, pregnancy-induced', 'pre-eclampsia', 'meditation', 'randomized clinical Trial'], 'conditions': ['Hypertension, Pregnancy-Induced', 'Hypertension in Pregnancy', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '23091073', 'type': 'BACKGROUND', 'citation': 'Gow AJ, Bastin ME, Munoz Maniega S, Valdes Hernandez MC, Morris Z, Murray C, Royle NA, Starr JM, Deary IJ, Wardlaw JM. Neuroprotective lifestyles and the aging brain: activity, atrophy, and white matter integrity. Neurology. 2012 Oct 23;79(17):1802-8. doi: 10.1212/WNL.0b013e3182703fd2.'}, {'pmid': '20332328', 'type': 'BACKGROUND', 'citation': 'Himelstein S. Meditation research: the state of the art in correctional settings. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):646-61. doi: 10.1177/0306624X10364485. Epub 2010 Mar 23.'}, {'pmid': '28709727', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28661961', 'type': 'BACKGROUND', 'citation': 'Fitton CA, Steiner MFC, Aucott L, Pell JP, Mackay DF, Fleming M, McLay JS. In-utero exposure to antihypertensive medication and neonatal and child health outcomes: a systematic review. J Hypertens. 2017 Nov;35(11):2123-2137. doi: 10.1097/HJH.0000000000001456.'}, {'pmid': '17764203', 'type': 'BACKGROUND', 'citation': 'Ospina MB, Bond K, Karkhaneh M, Tjosvold L, Vandermeer B, Liang Y, Bialy L, Hooton N, Buscemi N, Dryden DM, Klassen TP. Meditation practices for health: state of the research. Evid Rep Technol Assess (Full Rep). 2007 Jun;(155):1-263.'}, {'pmid': '18588603', 'type': 'BACKGROUND', 'citation': 'Kozasa EH, Radvany J, Barreiros MA, Leite JR, Amaro E Jr. Preliminary functional magnetic resonance imaging Stroop task results before and after a Zen meditation retreat. Psychiatry Clin Neurosci. 2008 Jun;62(3):366. doi: 10.1111/j.1440-1819.2008.01809.x. No abstract available.'}, {'pmid': '28222185', 'type': 'BACKGROUND', 'citation': 'Stahl JE, Dossett ML, LaJoie AS, Denninger JW, Mehta DH, Goldman R, Fricchione GL, Benson H. Correction: Relaxation Response and Resiliency Training and Its Effect on Healthcare Resource Utilization. PLoS One. 2017 Feb 21;12(2):e0172874. doi: 10.1371/journal.pone.0172874. eCollection 2017.'}, {'pmid': '12441200', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18317710', 'type': 'BACKGROUND', 'citation': 'Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Womens Ment Health. 2008;11(1):67-74. doi: 10.1007/s00737-008-0214-3. Epub 2008 Mar 3.'}, {'pmid': '18336440', 'type': 'BACKGROUND', 'citation': 'Beddoe AE, Lee KA. Mind-body interventions during pregnancy. J Obstet Gynecol Neonatal Nurs. 2008 Mar-Apr;37(2):165-75. doi: 10.1111/j.1552-6909.2008.00218.x.'}, {'pmid': '19538619', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24925904', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '15865489', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16008324', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25577496', 'type': 'BACKGROUND', 'citation': 'van den Heuvel MI, Johannes MA, Henrichs J, Van den Bergh BR. Maternal mindfulness during pregnancy and infant socio-emotional development and temperament: the mediating role of maternal anxiety. Early Hum Dev. 2015 Feb;91(2):103-8. doi: 10.1016/j.earlhumdev.2014.12.003. Epub 2015 Jan 8.'}, {'pmid': '22019563', 'type': 'BACKGROUND', 'citation': 'Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.'}, {'pmid': '19578654', 'type': 'BACKGROUND', 'citation': 'Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.'}, {'pmid': '11832252', 'type': 'BACKGROUND', 'citation': 'Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.'}, {'pmid': '15085902', 'type': 'BACKGROUND', 'citation': "Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00."}, {'pmid': '12703651', 'type': 'BACKGROUND', 'citation': 'Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.'}, {'pmid': '7850498', 'type': 'BACKGROUND', 'citation': 'Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'Primary research question:\n\nCan 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?\n\nSecondary research question:\n\nCan 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?\n\nDoes meditation practice increases (or decreases) the likelihood of change in Resilience indicators?\n\nDoes meditation practice increase (or decrease) the likelihood of change in anxiety and depression indicators?\n\nDoes meditation practice increase (or decrease) the likelihood of change in mindfulness indicators?\n\nDoes meditation practice increase (or decrease) the likelihood of change in quality of life indicators?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pre-existing hypertension.\n2. Single pregnancy, with gestational age between 20th and 24th weeks, with uncomplicated systemic arterial hypertension.\n3. Prenatal follow-up in a high-risk pregnancy clinic.\n4. No personal background of depression or psychiatric disorders.\n5. No serious heart disease.\n6. No illicit drugs and/or alcohol use.\n7. Acceptance of the informed consent.\n8. 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.\n\nExclusion Criteria:\n\n1. Diagnosis of depression and psychiatric disorders during pregnancy.\n2. Patients who do not return to follow-up or who want to quit the study.\n3. To practice meditation.'}, 'identificationModule': {'nctId': 'NCT03873194', 'briefTitle': 'Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension', 'orgStudyIdInfo': {'id': '93028218.7.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation 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.', 'interventionNames': ['Other: Meditation', 'Other: conventional treatment']}, {'type': 'OTHER', 'label': 'conventional treatment', 'description': 'Patients that will receive only the usual outpatient care, with the aim of observing the systemic blood pressure in this period.', 'interventionNames': ['Other: conventional treatment']}], 'interventions': [{'name': 'Meditation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Meditation group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': '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.\n\nDrug 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).', 'armGroupLabels': ['Meditation group', 'conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}