Comparison of Childbirth Satisfaction, Breastfeeding Self-Efficacy, and Perceived Stress in Syrian Migrant Women Receiving and Not Receiving Supportive Care During Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Childbirth Satisfaction
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of structured supportive midwifery care provided during labor on childbirth satisfaction, breastfeeding success, breastfeeding self-efficacy, and perceived stress among Syrian migrant women. A total of 100 eligible women admitted to the delivery unit of Yuregir State Hospital in Adana, Türkiye, will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Women in the intervention group will receive structured supportive midwifery care in addition to routine hospital care, whereas women in the control group will receive routine maternity care. The supportive care intervention will include physical support, emotional support, informational and communication support, and advocacy throughout labor. Outcomes will be assessed using validated measurement tools during the childbirth and early postpartum periods.
详细描述
This study is designed as a two-arm, parallel-group, randomized controlled trial. The study population will consist of Syrian migrant women admitted in active labor to the Delivery Unit of Yuregir State Hospital in Adana, Türkiye, who meet the eligibility criteria and provide written informed consent.
A total of 100 participants will be randomized in a 1:1 ratio to the intervention group (n=50) or control group (n=50). A variable block randomization procedure using block sizes of 4 and 6 will be used. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes.
Participants assigned to the intervention group will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four main components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes measures such as mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and other comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational support includes explanations about the labor process, procedures, breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy focuses on supporting women's preferences, participation in decision-making, privacy, and communication with healthcare professionals.
Participants assigned to the control group will receive the routine labor and postpartum care provided by the hospital without the additional structured supportive care intervention delivered by the researcher.
Study outcomes include childbirth satisfaction, breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool, postpartum breastfeeding self-efficacy, and perceived stress. Data will be collected at predefined time points from the beginning of labor through the first 24 hours postpartum.
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)
盲法说明
Participants will be blinded to group assignment. They will be informed that two different care approaches are being compared but will not be informed which group is designated as the intervention or control group or about the main study hypotheses. Due to the nature of the supportive care intervention, the researcher providing the intervention cannot be blinded to group assignment.
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
- •Syrian migrant women admitted to the Delivery Unit of Adana Yüreğir State Hospital due to labor.
- •Aged 18 years or older.
- •Gestational age between 37 and 42 weeks.
- •Singleton, live pregnancy.
- •Fetus in cephalic presentation.
- •Spontaneous vaginal labor initiated and in the active phase of labor.
- •Able to communicate in Arabic or Turkish at a level sufficient to understand the data collection instruments and the intervention to be applied.
- •Voluntarily agreeing to participate in the study and providing informed consent.
排除标准
- •Having a planned (elective) cesarean delivery decision at the time of admission.
- •Having an obstetric condition contraindicating vaginal delivery.
- •Having a high-risk pregnancy or labor condition, including severe preeclampsia, eclampsia, placenta previa, or placental abruption.
- •Multiple pregnancy.
- •Intrauterine fetal death or a major fetal anomaly incompatible with life.
- •Having a maternal or fetal clinical condition requiring emergency obstetric intervention at the time of admission for labor.
- •Having a cognitive impairment or severe psychiatric condition that would prevent participation, communication, or the informed consent process.
研究组 & 干预措施
Structured Supportive Midwifery Care
Participants assigned to this arm will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. Supportive care includes physical support, emotional support, informational and communication support, and advocacy.
干预措施: Structured Supportive Midwifery Care (Behavioral)
Routine Care
Participants assigned to this arm will receive the routine labor and postpartum care provided by Yuregir State Hospital. No additional structured supportive midwifery care will be provided by the researcher.
干预措施: Structured Supportive Midwifery Care (Behavioral)
结局指标
主要结局
Childbirth Satisfaction
时间窗: At 24 hours postpartum
Childbirth satisfaction will be assessed using the Mackey Childbirth Satisfaction Rating Scale. Higher total scores indicate higher levels of satisfaction with the childbirth experience.
次要结局
未报告次要终点
研究者
Özlem KOÇ
Principal Investigator
Tarsus University