Epigenetic and Cortisol Level Reflections of Maternal Stress During Pregnancy: A Randomized Controlled Trial on the Effectiveness of Educational Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Assessment of Pregnancy-Related Stress
研究概览
简要总结
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:
- Do stress management and epigenetic awareness training provided in prenatal classes affect pregnant women's cortisol levels?
- Does the training affect pregnant women's knowledge and awareness of epigenetic effects?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Education group
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.
干预措施: Maternal Epigenetics Training Module (Behavioral)
Control
The standard group that did not participate in the Maternal Epigenetics Training Module.
结局指标
主要结局
Assessment of Pregnancy-Related Stress
时间窗: 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.
Assessment of Pregnancy-Related Stress
时间窗: 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.
次要结局
- 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))
研究者
Emine Aksut Akcay
PhD, Assistant Professor
Kahramanmaras Sutcu Imam University