Effect of Midwife-Guided Birth Affirmation Cards on Labor Duration, Pain, Fear, Control and Perceived Support in Primigravidas: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Labor Duration
研究概览
简要总结
The aim of this study is to evaluate the effects of midwife-guided birth affirmation cards on labor duration, pain level, fear of childbirth, perceived control, and perceived support in primigravidas. The study seeks to determine whether this non-pharmacological approach used during labor improves the childbirth experience. Accordingly, the research aims to answer the question: "Do midwife-guided birth affirmation cards affect labor duration and the childbirth experience, including pain, fear, perceived control, and perceived support, in primigravidas?"
详细描述
This study is designed to investigate the use of birth affirmation cards, implemented under midwife guidance, as a non-pharmacological, low-cost, and feasible approach to support the labor process in primigravid women. Labor is not only a physiological process but also a multidimensional experience involving cognitive, emotional, and behavioral responses. Supporting a woman's sense of safety, enhancing coping capacity, and promoting a positive perception of childbirth are critical for improving the overall quality of the birth experience.
Birth affirmation cards are structured tools consisting of brief, positive, and empowering statements aimed at activating internal resources, strengthening self-efficacy, and fostering a positive cognitive framework toward childbirth. The implementation of these cards under midwife guidance ensures not only the delivery of supportive content but also continuous professional support, encouraging the active participation of the woman throughout labor. Therefore, the intervention is expected to contribute not only to psychological comfort but also to improved coping ability during childbirth.
The study will be conducted using a randomized controlled trial design. Participants allocated to the intervention group will receive midwife-guided birth affirmation card support during labor, while the control group will receive standard institutional care. The intervention content is structured around themes such as adaptation to labor, relaxation, confidence, resilience, trust in the body's ability to give birth, and the promotion of a positive childbirth perception. During implementation, the midwife will provide verbal support using the cards in accordance with the clinical condition of the participant and the stage of labor.
The innovative aspect of this study lies in evaluating birth affirmation cards not merely as individual psychological tools but as a structured, midwife-led supportive care intervention. Although existing literature highlights the importance of fear of childbirth, pain perception, perceived control, and perceived support in shaping the childbirth experience, randomized controlled studies examining the combined effects of affirmation-based interventions on these outcomes remain limited. Therefore, this study is expected to contribute to evidence-based midwifery practices and support the development of woman-centered supportive care strategies in labor.
The findings of this study are anticipated to support the integration of easily applicable, cost-effective, and potentially satisfaction-enhancing supportive care practices into routine maternity care. Additionally, promoting a positive childbirth experience may contribute to improved maternal psychological well-being and enhance the visibility and professional role of midwives in intrapartum care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician conducting data analysis will be blinded to group assignments. Participants, care providers, and investigators will not be blinded due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having a singleton pregnancy between 37-42 weeks of gestation
- •Being between 18-40 years of age
- •Being a primigravida
- •Having a cephalic presentation with vertex position
- •Being in the active phase of labor (cervical dilatation ≥4 cm)
- •Accepting non-invasive interventions
- •Having no mental or physical disability
- •Being able to understand and speak Turkish
- •Willingness to participate in the study
排除标准
- •High-risk pregnancies
- •Pregnant women at risk of intrapartum complications (e.g., oligohydramnios, polyhydramnios, intrauterine fetal demise, placenta previa, placental abruption, acute fetal distress, preeclampsia, fetal dystocia, macrosomia, etc.)
- •Pregnant women with a history of medical or obstetric complications
- •Women who have attended antenatal education classes (pregnancy school)
- •Women using epidural analgesia or other pharmacological pain management methods
- •Women experiencing communication difficulties
- •Women who are unwilling to participate in the study Exclusion Criteria from the Study
- •Experiencing dizziness, shortness of breath, or other discomfort,
- •Difficult and prolonged labor, instrumental delivery, placental retention, postpartum hemorrhage, need for neonatal intensive care,
- •Situations requiring emergency cesarean section during labor,
- •The woman will be excluded from the study if she ceases to cooperate during labor.
研究组 & 干预措施
Midwife-Guided Birth Affirmation Cards
Intervention Group: Participants will receive midwife-guided birth affirmation card support throughout labor in addition to standard care. The midwife will use structured affirmation cards containing positive, empowering statements tailored to the stage of labor and the participant's clinical condition, providing continuous verbal and emotional support.
干预措施: Midwife-Guided Birth Affirmation Cards (Other)
Control Group
Participants will receive routine institutional intrapartum care without the use of birth affirmation cards or additional structured supportive intervention.
结局指标
主要结局
Labor Duration
时间窗: Labor/delivery durations: - Stage 1 active phase (≥4 cm to full dilation), - The duration of Stage 2 (from full dilation to the baby's birth) is given in hours and minutes.
The researcher will monitor the duration of labor and interventions through the Birth Care Guide. The Birth Care Guide provides a structured monitoring framework aimed at conducting clinical monitoring systematically, based on evidence, and in a woman-centered manner throughout all stages of labor, from the moment the pregnant woman is admitted to the delivery unit. The guide is based on the World Health Organization's (WHO) positive birth experience and intrapartum care model, and includes the regular recording of clinical parameters related to the progress of labor (cervical dilation, uterine contractions, fetal and maternal monitoring findings), as well as principles of respectful maternal care such as continuous midwifery support, informed consent, effective communication, protection of privacy, supportive care practices, and joint decision-making.
labor pains
时间窗: Pain (VAS, 0-10 cm): - Applied once at 4 cm, 6 cm, 8 cm, - Full dilation is reached, - Stage 2.
The researcher will monitor labor pain using a VAS (Visual Analog Scale). The VAS will be used to measure the pain perceived by the individual. This scale was developed by Price et al. (1983) (Price et al., 1983). In this study, a 10 cm long Visual Analog Scale (VAS) will be used for pain assessment. The left end of the scale will be labeled '0 = no pain', and the right end will be labeled '10 = unbearable pain'.
Fear of Childbirth
时间窗: Fear (W-DEQ): - W-DEQ-A is administered during the early active phase (4-5 cm) - W-DEQ-B is administered within 2 hours after birth (when the mother is stable).
The researcher will monitor fear of childbirth using the W-DEQ A and B version. The scale consists of 33 items. Each item is a 6-point Likert scale with scores from 1 to 6, where 1 means "completely" and 6 means "not at all". The minimum possible score on the scale is 33, while the maximum score is 198. Higher scores indicate a higher level of fear of childbirth experienced by women.
Perception of Control and Support During Childbirth
时间窗: Sense of Control and Support (SCS): - Applied during the early active phase (4-5 cm) - within 2 hours after birth (when the mother is stable).
The Perception of Control and Support During Childbirth Scale will be used by the researcher. It is administered to assess women's perceptions of control and support during childbirth in the postpartum period. The Perception of Control and Support During Childbirth Scale consists of 33 items in total, comprising sub-dimensions of internal control, external control, and perceived support. The scale is a five-point Likert-type scale, where 1 means "strongly disagree" and 5 means "strongly agree". The lowest possible score is 33, and the highest is 165. A higher score indicates a higher perception of support and control during childbirth.
次要结局
未报告次要终点