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

NCT06841367 | Not Yet Recruiting

• 1 other identifier: 2011-KAEK-55
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preeclampsia Mild to Moderate

Keywords

preeclampsia; anxiety level; physiological parameters

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory

  The State-Trait Anxiety Inventory was developed by Spielberger and colleagues to measure state anxiety and trait anxiety. The final value obtained represents the individual's anxiety score. The scores obtained from both scales theoretically range between 20 and 80. A higher score indicates a higher level of anxiety. A lower score indicates a lower level of anxiety.

  two months

Secondary Outcomes (3)

• measurement of physiological parameters / arterial blood

  two months

• measurement of physiological parameters / heart rate

  two months

• measurement of physiological parameters / fever

  two months

Study Arms (2)

mindfulness-based stress reduction training

EXPERIMENTAL

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.

Other: Mindfulness-based stress reduction training

Control group

NO INTERVENTION

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.

Interventions

Mindfulness-based stress reduction training 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.

mindfulness-based stress reduction training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: It is aimed to ensure that pregnant women are minimally affected by the preeclampsia diagnosis they receive.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

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

  husniye.dinckaya@iuc.edu.tr

  PRINCIPAL INVESTIGATOR

• SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT

  sertap.mantarci@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT

CONTACT

+90 544 950 6396; sertap.mantarci@gmail.com

HÜSNİYE DİNÇ KAYA, ASSOCIATE PROFESSOR

CONTACT

+90 212 866 3700; husniye.dinckaya@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group will not receive mindfulness-based stress reduction training, and outcome assessments will be conducted by a researcher dependent on group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion: May 5, 2025
• Study Completion: July 15, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share