Meditation as Complementary Treatment for Chronic Hypertension in Pregnancy

Hypertension Clinical Trial

Official title:

Use of Meditation as a Complementary Therapy in the Treatment of Gestational Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873194
• Other study ID #: 93028218.7.0000.0068
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2020
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 30, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

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.
• 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).

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (21)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Gow AJ, Bastin ME, Muñoz Maniega S, Valdés Hernández 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Assessment of quality of life with World Health Organization instrument for evaluating quality of life (Whoqol-bref) questionnaire.	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.	8 weeks
Secondary	Assessment of anxiety and depression with The Hospital Anxiety and Depression Scale (HADS).	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.	8 weeks
Secondary	Assessment of the capacity to adapt and restore equilibrium to their lives and avoid the potentially deleterious effects of stress with Resilience Scale.	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.	8 weeks
Secondary	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)	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.	8 weeks