The Effect of Awareness-Based Stress Reduction Training on Preeclampsia and Anxiety

NCT ID: NCT06841367

Last Updated: 2025-02-24

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-07-15

Brief Summary

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Preeclampsia is a multisystem disease that occurs during pregnancy and carries risks into the postpartum period. This condition, which threatens maternal and fetal health, requires close monitoring and good care. Pregnant women need to rely on both their previously used coping mechanisms and learn new coping methods to manage the stress associated with high-risk pregnancies. Complementary and integrative therapies are utilized in managing hypertensive disorders and anxiety during pregnancy. Literature reviews show that complementary medicine practices included in current care may be effective in alleviating the symptoms of preeclampsia and reducing anxiety levels. However, the existing scientific studies are not at a sufficient level of evidence, and more advanced studies are needed in this area.

The aim of our thesis study is to examine the effect of mindfulness-based stress reduction training on anxiety levels and physiological parameters in pregnant women diagnosed with preeclampsia.

Detailed Description

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Preeclampsia is a condition characterized by hypertension and proteinuria that occurs after the 20th week of pregnancy. The anxiety and fear experienced by pregnant women diagnosed with preeclampsia about their own and their baby's well-being lead to an increase in anxiety levels.

Mindfulness has been defined as the awareness of one's present-moment experience, accompanied by an attitude of kindness, friendliness, and non-judgmental acceptance .

Mindfulness-Based Stress Reduction (MBSR) is a clinical program that provides systematic training in mindfulness meditation as a self-regulation approach to facilitate adjustment to medical conditions, reduce stress, and manage emotions.

In a study conducted to determine the effect of mindfulness training on lowering blood pressure in preeclamptic women, a decrease in systolic and diastolic blood pressure was observed.

A study examining the effects of mindfulness training on maternal anxiety and self-efficacy in relation to childbirth found that anxiety levels decreased in pregnant women, and it was recommended that healthcare providers and pregnant women participate in mindfulness programs to improve pregnancy outcomes and childbirth.

It has been determined that mindfulness-based interventions during pregnancy can be beneficial for outcomes such as anxiety, depression, perceived stress, and mindfulness levels in the perinatal period.

Mindfulness-based training for the psychological health of pregnant women has been reported to significantly reduce perceived stress and depression, while increasing mindfulness and self-efficacy in women.

Mindfulness-based stress reduction training aimed at examining its effects on stress, anxiety, and prenatal attachment in high-risk pregnancies was found to reduce anxiety, increase prenatal attachment, and have no effect on stress levels in pregnant women .

A meta-analysis examining the effects of diet, exercise, yoga, and mindfulness practices during pregnancy to prevent hypertensive disorders found that these lifestyle interventions reduced the incidence of hypertension in pregnancy.

The aim of our thesis study is to examine the effect of mindfulness-based stress reduction training on anxiety levels and physiological parameters in pregnant women diagnosed with preeclampsia.

Conditions

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Preeclampsia Mild to Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a study with a randomized controlled experimental design. Two groups with preeclampsia will be included in the study. Experimental group (group receiving mindfulness training), Control group (group without intervention)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The control group will not receive mindfulness-based stress reduction training, and outcome assessments will be conducted by a researcher dependent on group allocation.

Study Groups

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mindfulness-based stress reduction training

The participants' anxiety levels and physiological parameters will be measured at the initial stage. For 8 weeks in the intervention group, conscious awareness-based stress reduction training will be given online for 1 hour a week. Control at week 4 and Interim evaluations will be provided for intervention groups. At the end of the 8th week, anxiety level and physiological parameters were again will be evaluated.

Group Type EXPERIMENTAL

Mindfulness-based stress reduction training

Intervention Type OTHER

It is expected that improvements in physiological parameters and anxiety levels will be observed in the preeclampsia group with awareness-based stress reduction training.

Control group

The participants' anxiety levels and physiological parameters will be measured at the initial stage. No intervention will be made to the control group. Physiological parameters and anxiety levels will be measured at the 4th and 8th weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based stress reduction training

It is expected that improvements in physiological parameters and anxiety levels will be observed in the preeclampsia group with awareness-based stress reduction training.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Knowing Turkish
* Being literate
* Being over 18
* Being primiparous
* Having a singleton fetus and cephalic presentation
* Being diagnosed with preeclampsia
* Agreeing to participate in the study

Exclusion Criteria

* Having any additional disease other than preeclampsia
* Participant's voluntary withdrawal from the study
* Having a cesarean section for any reason
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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SERTAP MANTARCI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Istanbul University-Cerrahpaşa Faculty of Health Sciences Postgraduate Education Institute, ASSOCIATE PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

[email protected]

SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Central Contacts

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SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT

Role: CONTACT

+90 544 950 6396

HÜSNİYE DİNÇ KAYA, ASSOCIATE PROFESSOR

Role: CONTACT

+90 212 866 3700 ext. 40136

Other Identifiers

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2011-KAEK-55

Identifier Type: -

Identifier Source: org_study_id

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