The Effect of Reflexology Treatment on Maternal Anxiety During Induction of Labor With an Extra-amniotic Balloon
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Maternal anxiety during labor as perceived by the validated state-trait anxiety index
研究概览
简要总结
This prospective, randomized controlled trial evaluates the effect of reflexology on maternal anxiety, labor duration, and pain in women undergoing labor induction with an extra-amniotic balloon (EAB). Eligible participants are women with a singleton, term pregnancy, cephalic presentation, intact membranes, and a Bishop score <6, without prior cesarean delivery or contraindications to vaginal delivery.
Participants will be randomized to two groups: an intervention group receiving reflexology by a certified practitioner following EAB placement, and a control group receiving standard care. Maternal anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) before and after the intervention. Labor duration and pain scores will also be recorded.
The study plans to enroll 84 participants over two years. Reflexology is a safe, non-invasive complementary therapy, and this study aims to determine whether it provides measurable benefits during labor induction.
详细描述
Labor induction is a common obstetric procedure that can be associated with maternal anxiety, pain, and prolonged labor, potentially affecting the birth experience and maternal well-being. Complementary interventions may help reduce these effects and improve patient satisfaction.
Reflexology is a non-invasive therapy involving targeted pressure on specific points of the feet, hands, or ears, which may promote relaxation and reduce stress and pain. Preliminary evidence suggests reflexology can decrease maternal anxiety and labor pain, but high-quality data in the context of mechanically induced labor are limited.
This study evaluates reflexology during labor induced with an extra-amniotic balloon (EAB). Participants will be randomized to receive either reflexology by a trained practitioner after EAB placement or standard care without reflexology. Maternal anxiety, labor duration, pain, and patient satisfaction will be systematically assessed, using validated measures for anxiety and pain, along with routine clinical and neonatal data collected from hospital records.
The study aims to enroll 84 participants over two years. All participants will provide informed consent, and data will be de-identified to ensure privacy. This trial seeks to provide evidence on the efficacy of reflexology as a complementary intervention during labor induction, informing clinical practice and enhancing maternal-centered care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of ≥18 years
- •Gestational age of >37 weeks
- •Vertex presentation
- •Intact membranes
- •Station of the fetus's head < S-4
- •Bishop score of <6.
排除标准
- •Patients who had undergone a previous cesarean delivery
- •Patients with a contraindication for vaginal delivery
- •Patients with a known fetal malformation patients undergoing termination of pregnancy.
研究组 & 干预措施
reflexology during induction of labor
Participants randomized to this arm will receive a reflexology treatment administered by a certified reflexologist. The session will occur shortly after placement of the extra-amniotic balloon (EAB) for labor induction and before the balloon's spontaneous expulsion or removal at 24 hours. Reflexology will be performed on specific pressure points on the feet, following a standardized protocol intended to reduce maternal anxiety and pain. Participants will also receive routine obstetric care as per institutional protocol.
干预措施: Reflexology (Other)
Standard care
Participants randomized to this arm will receive standard obstetric care for labor induction with an extra-amniotic balloon (EAB) according to the hospital's clinical protocol. No reflexology or sham procedure will be administered. Anxiety and pain assessments will be conducted at comparable time points to those in the intervention group.
结局指标
主要结局
Maternal anxiety during labor as perceived by the validated state-trait anxiety index
时间窗: first STAI questionnaire after recruitment and before induction initiation to assess baseline anxiety. Within 2-10 hours of EAB placement she will fill the second STAI form (similar) and delta STAI score will be calculated
state-trait anxiety index (STAI-S) questionnaire
次要结局
- Neonatal hypoglycemia(Within first 24 hours after birth)
- Time from Extra-Amniotic Balloon (EAB) placement to balloon expulsion(From the time of EAB placement until the time of balloon expulsion, assessed up to 24 hours after placement.)
- Time from labor induction to delivery(From the time of EAB placement until the time of delivery, assessed up to 72 hours after induction initiation.)
- Pain during labor induction as measured by the Visual Analogue Scale (VAS)(Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.)
- Mode of delivery(At delivery)
- Maternal satisfaction with the labor induction experience(up to 1 hour from intervention and prior to delivery)
- Manual lysis of placenta(At delivery)
- Neonatal birthweight(At 1 minute and 5 minutes after birth)
- Umbilical cord pH(At birth)
- NICU admission(Immediately after birth, assessed through hospitalization period (up to 28 days))
- Respiratory distress syndrome (RDS)(During initial hospitalization (up to 28 days of life))
- Neonatal ventilation(During initial hospitalization (up to 28 days))
- Neonatal neurological morbidity(During initial hospitalization (up to 28 days))
- Neonatal blood transfusion(During neonatal hospitalization (up to 28 days))
- Neonatal phototherapy(During neonatal hospitalization (up to 28 days))
- Neonatal death(Up to 28 days after birth)
- Time from Extra-Amniotic Balloon (EAB) placement to balloon expulsion(From the time of EAB placement until the time of balloon expulsion, assessed up to 24 hours after placement.)
- Time from labor induction to delivery(From the time of EAB placement until the time of delivery, assessed up to 72 hours after induction initiation.)
- rate of vaginal birth within 24 hours from induction(24 hours from induction initiation to delivery)
- Pain during labor induction as measured by the Visual Analogue Scale (VAS)(Baseline before EAB placement and post-intervention or within 2-10 hours after EAB placement.)
- Mode of delivery(At delivery)
- Maternal satisfaction with the labor induction experience(up to 1 hour from intervention and prior to delivery)
- Intrapartum fever(During labor, up to delivery)
- Manual lysis of placenta(At delivery)
- Neonatal birthweight(At 1 minute and 5 minutes after birth)
- Umbilical cord pH(At birth)
- NICU admission(Immediately after birth, assessed through hospitalization period (up to 28 days))
- Respiratory distress syndrome (RDS)(During initial hospitalization (up to 28 days of life))
- Neonatal ventilation(During initial hospitalization (up to 28 days))
- Neonatal neurological morbidity(During initial hospitalization (up to 28 days))
- Neonatal hypoglycemia(Within first 24 hours after birth)
- Neonatal blood transfusion(During neonatal hospitalization (up to 28 days))
- Neonatal phototherapy(During neonatal hospitalization (up to 28 days))
- Neonatal death(Up to 28 days after birth)