Preeclampsia Mild to ModerateNCT06841367
The Effect of Awareness-Based Stress Reduction Training on Preeclampsia and Anxiety
A study testing Mindfulness-based stress reduction training in people with Preeclampsia Mild to Moderate, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preeclampsia Mild to Moderate
- What is being tested?
- Mindfulness-based stress reduction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Having any additional disease other than preeclampsia
- Participant's voluntary withdrawal from the study
- Having a cesarean section for any reason
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
HÜSNİYE DİNÇ KAYA, ASSOCIATE PROFESSOR contact
About this study
Official title: The Effect of Awareness-Based Stress Reduction Training on Anxiety Level and Physiological Parameters in Pregnant Women Diagnosed With Preeclampsia
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.
Read the 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.
- Conditions
- Preeclampsia Mild to Moderate
- Being tested
- Mindfulness-based stress reduction training
- Keywords
- preeclampsia, anxiety level, physiological parameters
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction trainingOther
It is expected that improvements in physiological parameters and anxiety levels will be observed in the preeclampsia group with awareness-based stress reduction training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Secondary outcomes (3)
measurement of physiological parameters / arterial blood
Arterial blood pressure will be measured with a manual device and a stethoscope. Blood pressure will be expressed in mmHg. Blood pressure values above 140/90 mmHg will be considered high, while values below 140/90 mmHg will be considered normal.
Measured: two months
measurement of physiological parameters / heart rate
The heart rate will be measured by counting the brachial artery beats for 60 seconds with the help of a stopwatch. The unit will be expressed as beats per minute (bpm).
Measured: two months
measurement of physiological parameters / fever
Fever will be measured with a thermometer. The unit for the fever parameter is expressed in °C. Fever values below 36.0 °C and above 37.5 °C will be considered abnormal.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion5 May 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia Mild to ModerateStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERTAP MANTARCI, Istanbul University - Cerrahpasa
- Investigators
- Istanbul University-Cerrahpaşa Faculty of Health Sciences Postgraduate Education Institute, ASSOCIATE PROFESSOR, Principal investigator, husniye.dinckaya@iuc.edu.trSERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT, Principal investigator, sertap.mantarci@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841367
- Sponsor's protocol ID
- 2011-KAEK-55
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Awareness-Based Stress Reduction Training on Anxiety Level and Physiological Parameters in Pregnant Women Diagnosed With Preeclampsia
- ClinicalTrials.gov ID
- NCT06841367
- Acronym / sponsor ID
- 2011-KAEK-55
- Conditions
- Preeclampsia Mild to Moderate
- Keywords
- preeclampsia, anxiety level, physiological parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based stress reduction training | Experimental | Other: Mindfulness-based stress reduction trainingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Knowing Turkish
- Being literate
- Being over 18
- Being primiparous
- Having a singleton fetus and cephalic presentation
Key exclusion criteria (3 listed)
- Having any additional disease other than preeclampsia
- Participant's voluntary withdrawal from the study
- Having a cesarean section for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction trainingIt is expected that improvements in physiological parameters and anxiety levels will be observed in the preeclampsia group with awareness-based stress reduction training. | Other | mindfulness-based stress reduction training |
Primary outcome
State-Trait Anxiety Inventory
Time frame: two months
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.
3 secondary outcomes
measurement of physiological parameters / arterial blood
Time frame: two months
measurement of physiological parameters / heart rate
Time frame: two months
measurement of physiological parameters / fever
Time frame: two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HÜSNİYE DİNÇ KAYA, ASSOCIATE PROFESSOR contact
Istanbul University-Cerrahpaşa Faculty of Health Sciences Postgraduate Education Institute, ASSOCIATE PROFESSOR principal investigator
husniye.dinckaya@iuc.edu.tr
SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT principal investigator
sertap.mantarci@gmail.com
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction training in people with Preeclampsia Mild to Moderate, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SERTAP MANTARCI, MIDWIFERY GRADUATE STUDENT (+90 544 950 6396, sertap.mantarci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.