Clinical trial NCT06841367: The Effect of Awareness-Based Stress Reduction Training on Preeclampsia and Anxiety
Official title: The Effect of Awareness-Based Stress Reduction Training on Anxiety Level and Physiological Parameters in Pregnant Women Diagnosed With Preeclampsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preeclampsia Mild to Moderate
Keywords: preeclampsia
anxiety level
physiological parameters
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: two months
Secondary outcomes:
measure: measurement of physiological parameters / arterial blood
timeFrame: two months
measure: measurement of physiological parameters / heart rate
timeFrame: two months
measure: measurement of physiological parameters / fever
timeFrame: two months
Other outcomes:
Locations:
Study officials:
affiliation: husniye.dinckaya@iuc.edu.tr
name: Istanbul University-Cerrahpaşa Faculty of Health Sciences Postgraduate Education Institute, ASSOCIATE PROFESSOR
role: PRINCIPAL_INVESTIGATOR
affiliation: sertap.mantarci@gmail.com
name: SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT
role: PRINCIPAL_INVESTIGATOR
References: