Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy

NCT07764380 | Recruiting

• 1 other identifier: KSUESRAKARATASOKYAY007
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (2)

• Assessment of Pregnancy-Related Stress

  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.

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

• Assessment of Pregnancy-Related Stress

  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.

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

Secondary Outcomes (4)

• Measuring pregnant women's awareness of epigenetic effects and stress

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

• Measuring pregnant women's awareness of epigenetic effects and stress

  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)

• Cortisol level measurement

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

• Cortisol level measurement

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

Study Arms (2)

Education group

EXPERIMENTAL

The Maternal Epigenetics Training Module will be conducted over a three-week period, consisting of a total of three sessions held once a week. The training will include an informational presentation covering 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 impact of the mother's lifestyle on fetal health.

Behavioral: Maternal Epigenetics Training Module

Control

NO INTERVENTION

The standard group that did not participate in the Maternal Epigenetics Training Module.

Interventions

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.

Education group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Emine Aksüt Akçay

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

Kahramanmaras Sutcu Imam University

Kahramanmaraş, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Dieckmann L, Czamara D. Epigenetics of prenatal stress in humans: the current research landscape. Clin Epigenetics. 2024 Feb 2;16(1):20. doi: 10.1186/s13148-024-01635-9.

  PMID: 38308342 BACKGROUND

Related Links

• Related Info

Study Officials

• ESRA KARATAŞ OKYAY, PhD

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

Central Study Contacts

İsmail Gürkan Çıkım, Professor

CONTACT

(344) 310-0000; ismailgurkancikim@ksu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Model Details: Randomized controlled trial conducted with experimental and control groups.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: August 13, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

TU (2)