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NCT Number: NCT07764380

Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy

The aim of this study is to evaluate the effects of stress management and epigenetic awareness training provided in prenatal classes on maternal stress levels, cortisol levels, and epigenetic awareness.

The main questions it aims to answer are:

1. Do stress management and epigenetic awareness training provided in prenatal classes affect pregnant women's cortisol levels? 2. Does the training affect pregnant women's knowledge and awareness of epigenetic effects?

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emine Aksüt Akçay, Kahramanmaraş, Turkey (Türkiye)

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About this study

The study sample will be selected using random sampling from among pregnant women who apply to the Prenatal Education Program at Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. The study was conducted using a quasi-experimental design with an experimental and control group, employing a pre-test-post-test approach. A portion of the pregnant women, selected through random assignment, will be included in the experimental group, while the remaining portion will be included in the control group. Data will be collected by the researcher through face-to-face interviews at the Prenatal Education School of Kahramanmaraş Sütçü İmam University Faculty of Medicine Hospital. Each face-to-face interview will last approximately 15-30 minutes. The study will be conducted with two groups: the Maternal Epigenetic Education Module intervention group (intervention) and the control group.

Prior to the start of the educational program, pre-test data will be collected from participants in the intervention group by administering the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form. Additionally, saliva samples will be collected to determine participants' cortisol levels. The Maternal Epigenetic Education Module will be conducted over three weeks, consisting of a total of three sessions held once a week. The educational presentation will cover stress management, the potential effects of stress during pregnancy on the mother, the potential effects of stress during pregnancy on the fetus, epigenetic mechanisms, and the effects of the mother's lifestyle on fetal health. Following the completion of the training program, the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form will be administered again to obtain final test data, and saliva samples will be collected once more to measure cortisol levels. For participants in the control group, only two interviews will be conducted. During the first interview, the Personal Information Form, the Pregnancy Stress Assessment Scale, and the Epigenetic Awareness and Knowledge Form will be administered, and a saliva sample will be collected.

At the second follow-up visit, which will take place four weeks later, final data will be collected using the Pregnancy Stress Assessment Scale and the Epigenetic Awareness and Knowledge Form, and saliva samples will be collected again for cortisol measurement. The stress levels, epigenetic awareness levels, and cortisol levels of the pregnant women will be measured before and after the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged 18 and older
  • Pregnant women in any trimester of pregnancy
  • Pregnant women who can read and understand Turkish
  • Pregnant women who voluntarily agree to participate in the study
  • Having a singleton pregnancy
  • Pregnant women without a high-risk pregnancy
  • Pregnant women who voluntarily participate in prenatal education classes will be included.

Exclusion criteria

  • Foreign nationals with communication difficulties,
  • Multiple pregnancies,
  • Illiterate pregnant women,
  • Migrant pregnant women who do not speak Turkish,
  • Pregnant women with high-risk pregnancies,
  • Pregnant women not enrolled in prenatal education programs,
  • Pregnant women with intellectual disabilities,
  • Pregnant women who refuse to participate in the study will be excluded.

Treatment and study plan

Maternal Epigenetics Training Module

Behavioral

The Maternal Epigenetics Education Module is a structured educational intervention designed to reduce stress levels in expectant mothers during pregnancy, raise their awareness of the effects of stress on both the mother and the fetus, and promote healthy lifestyle behaviors within the framework of epigenetic mechanisms. The module addresses the relationship between stress, epigenetics, and fetal health during pregnancy from a scientific perspective and aims to equip expectant mothers with basic skills for managing stress.

Primary outcomes

  1. Assessment of Pregnancy-Related Stress

    Time frame: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (day 1)

    The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.

  2. Assessment of Pregnancy-Related Stress

    Time frame: Pregnancy Stress Assessment Scale will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)

    The Pregnancy Stress Assessment Scale , used to identify pregnancy-related stress factors in pregnant women. The scale consists of 36 items and 5 subscales. Range from a minimum of 0 to a maximum of 144 points. Higher scores on the scale are interpreted as indicating increased stress.

Secondary outcomes

  1. Measuring pregnant women's awareness of epigenetic effects and stress

    Time frame: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (day 1)

    This is a short questionnaire developed by the researcher to measure pregnant women's awareness of epigenetic effects and stress. It was designed to determine the level of awareness regarding the impact of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the education provided, and was prepared by the researcher to assess the effect of maternal stress on epigenetic awareness. This form is designed to measure pregnant women's awareness of the effects of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the level of awareness regarding the education provided at the Prenatal Education Program (Nowak et al., 2020). It will be evaluated based on the pregnant women's experiences and knowledge over the past month.

  2. Measuring pregnant women's awareness of epigenetic effects and stress

    Time frame: Epigenetic Awareness and Information Form will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)

    This is a short questionnaire developed by the researcher to measure pregnant women's awareness of epigenetic effects and stress. It was designed to determine the level of awareness regarding the impact of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the education provided, and was prepared by the researcher to assess the effect of maternal stress on epigenetic awareness. This form is designed to measure pregnant women's awareness of the effects of stress during pregnancy on the baby's genetic and epigenetic structure, the importance of lifestyle changes, and the level of awareness regarding the education provided at the Prenatal Education Program (Nowak et al., 2020). It will be evaluated based on the pregnant women's experiences and knowledge over the past month.

  3. Cortisol level measurement

    Time frame: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (day 1)

    Cortisol levels will be measured using saliva samples from pregnant women. Cortisol samples will be collected on an empty stomach between 8:00 and 9:00 a.m., and two samples will be collected from each participant-one before the training and one after the training.

  4. Cortisol level measurement

    Time frame: Salivary cortisol level will be administered to all pregnant women in both groups at the first interview (At the end of Week 3)

    Cortisol levels will be measured using saliva samples from pregnant women. Cortisol samples will be collected on an empty stomach between 8:00 and 9:00 a.m., and two samples will be collected from each participant-one before the training and one after the training.

Study contacts

Contact information is provided by the study sponsor or research team.

İsmail Gürkan Çıkım, Professor

CONTACT

[email protected]

(344) 310-0000

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy: A Randomized Controlled Trial on the Effectiveness of Educational Programs

Acronym: Maternal Stres

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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