The Effect of Mindfulness-Based Childbirth Education on Psychosocial Outcomes in Pregnant Women: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Self-Efficacy in Labor
研究概览
简要总结
The study was conducted as a prospective, randomized controlled study to determine the effect of Mindfulness-Based Childbirth Education on psychosocial outcomes in pregnant women. Pregnant women applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Obstetrics and Gynecology, Pregnancy Polyclinic and Faculty Member Polyclinic between 15.09.2021-28.06.2022. A total of 82 pregnant women were included in the experimental and control groups. The experimental group received Mindfulness-Based Childbirth Education for 8 weeks and the control group received Information-Based Childbirth Education for 4 weeks. Evaluation was performed in both groups before and after the training and at the end of the 4th postpartum week. The data were collected using the Introductory Information Form, Perceived Stress Scale, Edinburg Postpartum Depression Scale, Birth Self-Efficacy Scale and City Birth Trauma Scale.
详细描述
This prospective, randomized controlled study was conducted to determine the effect of Mindfulness-Based Childbirth Education on psychosocial outcomes in pregnant women. In this randomized controlled intervention study, the "Consolidated Standards for Reporting Studies (CONSORT) 2018" guideline was followed. It was conducted with pregnant women who applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty using Zoom program, a web-based application. Faculty of Medicine, Department of Obstetrics and Gynecology, Pregnancy Polyclinic and Faculty Member Polyclinic, between 15.09.2021-28.06.2022. A total of 82 pregnant women were included in the experimental and control groups.
Preliminary Preparation and Creation of Education Content: The primary researcher (SOA) who provided the training received a Certificate of Mindfulness and Childbirth Preparedness Trainer Training. In order to evaluate the suitability of the content and scope of the Mindfulness-Based Childbirth Education, which was prepared in line with the literature, to the training received by the researcher, the opinions of 4 experts working on mindfulness and childbirth preparation training were obtained. The content of the training was prepared in line with the feedback received from the experts. Eight sessions were carried out as a pilot application to four pregnant women in order to determine the suitability of the content of the Mindfulness-Based Childbirth Education Training, to plan the duration of the training and to determine the points that were not understood in the training. At the end of the pilot application, the training content was finalized. Pilot application data were not included in the study.
Group Formation: The groups were randomized into two groups by an independent researcher using the web-based randomization program randomizer.org. Pregnant women who met the inclusion criteria were assigned numbers according to the sequence numbers obtained using the randomization program.
Interventions:
Information-Based Childbirth Education: The content of Information-Based Childbirth Education includes topics such as "Physical and mental preparation for childbirth, the birth process, non-drug methods that reduce birth pain and facilitate birth, postpartum period characteristics, physiological and psychological changes in the mother after birth, adaptation to the role of motherhood. newborn care." Since the pregnant women were included in the study starting from the 20th week, pregnancy-related topics were not included in the training content. The training program is organized for four hours each week for four weeks. At least four pregnant women attended each session. It was completed on the alternative training day planned for pregnant women who could not attend. Participants were given homework assignments at the end of each session and asked to complete these assignments by the next training session. After the training, the postpartum women were reminded weekly via WhatsApp until the end of the fourth week after the birth of the baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being at least 18 years old
- •Being primiparous
- •To be at least primary school graduate,
- •Not having a risky pregnancy,
- •Being between 20-26 weeks of pregnancy,
- •Those who volunteered to participate in the study,
- •Having internet access and equipment (computer, smart phone, etc.).
排除标准
- •Being multiparous
- •To have taken yoga or mindfulness training during pregnancy or before,
- •Pregnant women with communication problems (related to hearing, speaking and understanding),
- •Receiving psychiatric treatment during pregnancy or postpartum period.
- •Pregnant women who want to leave the study,
- •Those who were diagnosed with risky pregnancy during the research (preeclampsia, threat of premature birth, etc.),
- •Pregnant women who do not attend 70% of the education.
结局指标
主要结局
Self-Efficacy in Labor
时间窗: From the beginning of the study to the end of training and birth
Self-efficacy levels of pregnant women were evaluated before and after the training. A total of 2 measurements were made. "Self-Efficacy in Childbirth Scale" was used to assess the level of self-efficacy. The Self-Efficacy in Childbirth Scale evaluates women's self-efficacy level regarding childbirth. The scale has two subscales. The minimum score that can be obtained from each subscale is 16 and the maximum score is 160. The minimum score that can be obtained from the whole scale is 32 and the maximum total score is 320. Higher scores obtained from the scale indicate that pregnant women have higher levels of self-efficacy for childbirth.
Perceived Stress
时间窗: from the beginning of the study to the fourth week postpartum
The perceived stress level of pregnant women before and after the training was evaluated. Perceived stress level was re-evaluated at the 4th week postpartum. "Perceived Stress Scale (PSS)" was used to evaluate the perceived stress level. Perceived Stress Scale consists of a total of 14 items and evaluates individuals' stress perceptions against certain situations they encounter in their lives. The scale has a five-point Likert rating. The scale has two subscales called "perception of insufficient self-efficacy" and "perception of stress/discomfort".The lowest score that can be obtained from PSS-14 is 0 and the highest score is 56. An increase in the scores people get from the scale indicates that their perception of stress increases.
Symptoms of post traumatic stretch disorder
时间窗: In the fourth week postpartum
Postpartum posttraumatic stress disorder (PTSD) symptoms were assessed only at the fourth postpartum week using the City Birth Trauma Scale. The four-point Likert-type scale consists of 29 items and five subscales. The sub-dimensions are re-experiencing, avoidance symptoms, negative cognitions and mood, hyperarousal and dissociative symptoms. The City Birth Trauma Scale is used to assess symptoms of Posttraumatic Stress Disorder (PTSD) and is not a diagnostic tool. A higher score on the scale means that posttraumatic stress symptoms are more prevalent and reflects a greater risk for Posttraumatic Stress Disorder (PTSD).
Edinburgh Postpartum Depression Incidence
时间窗: From the beginning of the study (pre-training) to the fourth week postpartum.
The depression symptoms of the pregnant women were evaluated 3 times in total, before, after and at the fourth week after delivery. Edinburgh Postpartum Depression Scale was used in the evaluation. Self-efficacy levels of pregnant women were evaluated before and after the training. A total of 2 measurements were made. The "Self-Efficacy in Childbirth Scale" was used to assess the level of self-efficacy. The Self-Efficacy in Childbirth Scale evaluates women's self-efficacy level regarding childbirth. The scale has two subscales. The minimum score that can be obtained from each subscale is 16 and the maximum score is 160. The minimum score that can be obtained from the whole scale is 32 and the maximum total score is 320. Higher scores obtained from the scale indicate that pregnant women have higher levels of self-efficacy for childbirth.
次要结局
未报告次要终点
研究者
Sibel OCAK AKTURK
Principal Investigator
Çanakkale Onsekiz Mart University