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临床试验/NCT07299708
NCT07299708已完成不适用

Effects of Sleep Quality, Anxiety, and Digital Behavior on Labor Progression in Term Primiparous Women: A Prospective Observational Study

Tepecik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
Duration of Active Labor

研究概览

简要总结

This prospective observational study evaluates whether maternal sleep quality, anxiety levels, and nighttime digital behavior are associated with labor progression among term primiparous women. Sleep quality and anxiety are assessed before the onset of labor during routine antenatal visits using validated instruments, including the Pittsburgh Sleep Quality Index (PSQI) and the Beck Anxiety Inventory (BAI). Nighttime digital behavior characteristics, such as screen exposure and smartphone use prior to sleep, are recorded through standardized antenatal interviews.

Labor outcomes, including the duration of the latent, active, and second stages of labor, requirement for oxytocin augmentation, use of analgesia, and mode of delivery, are prospectively documented from hospital admission until birth. By examining behavioral and psychological factors prior to labor onset, the study aims to determine whether poor sleep quality, increased anxiety, or irregular nighttime digital activity are associated with prolonged labor phases or greater need for obstetric interventions.

详细描述

This prospective observational cohort study investigates the influence of maternal sleep quality, anxiety levels, and nighttime digital device use on labor progression among term primiparous women. Eligible participants were term primiparous women attending routine antenatal follow-up at Izmir Tepecik Training and Research Hospital. All psychosocial assessments were completed prior to the onset of labor. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), and anxiety levels were assessed using the Beck Anxiety Inventory (BAI). Nighttime digital behavior characteristics were documented through structured antenatal interviews and included pre-sleep screen exposure, smartphone use in bed, frequency of nighttime phone checking, and the type of digital content viewed before sleep.

Participants were subsequently followed through spontaneous labor, and labor-related data were collected prospectively. Initial labor characteristics documented at hospital admission included cervical dilation, contraction pattern, and overall clinical presentation. Additional labor outcomes, including the duration of the latent, active, and second stages of labor, use of oxytocin augmentation, requirement for epidural or opioid analgesia, operative vaginal delivery, cesarean delivery, and neonatal outcomes, were recorded systematically according to standardized institutional protocols.

The primary aim of the study is to determine whether poor sleep quality, elevated anxiety levels, or increased nighttime digital device use are associated with prolonged labor or dysfunctional labor patterns. Secondary aims include examining whether interactions between digital behavior variables and psychological factors contribute to variations in maternal labor physiology or to increased obstetric intervention rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women at ≥ 37 weeks of gestation
  • Completion of PSQI (sleep quality) and BAI (anxiety) assessments during antenatal clinic visit
  • Singleton pregnancy
  • Cephalic presentation
  • Age 18 to 50 years
  • Planning to deliver at the study hospital
  • Able to provide informed consent

排除标准

  • Multiple pregnancy
  • Non-cephalic presentation
  • Delivery occurring at another hospital or birth center
  • Elective planned cesarean delivery
  • Major fetal anomaly
  • Placenta previa or placenta accreta spectrum
  • Preeclampsia, eclampsia, HELLP syndrome
  • Gestational diabetes requiring insulin
  • Chronic medical disorders affecting labor physiology
  • Use of sedative, hypnotic, or psychotropic medications
  • Inability to complete questionnaires

结局指标

主要结局

Duration of Active Labor

时间窗: From onset of active labor (≥4 cm) until full cervical dilatation (10 cm), typically within 2 to 12 hours.

Time in minutes from the onset of active labor (defined as cervical dilatation of ≥4 cm with regular contractions) to full cervical dilatation (10 cm). Data will be obtained prospectively from electronic delivery records.

次要结局

  • Duration of Latent Phase of Labor(From onset of regular contractions until onset of active labor (≥4 cm), typically lasting up to 20 hours.)
  • Duration of Second Stage of Labor(From full dilatation (10 cm) until birth, typically lasting up to 3 hours.)
  • Oxytocin Augmentation Requirement(From admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.)
  • Mode of Delivery(Assessed at delivery.)
  • APGAR Score at 1 and 5 Minutes(Assessed at 1 and 5 minutes after birth.)
  • Use of Epidural Analgesia(From onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.)
  • Neonatal Intensive Care Unit (NICU) Admission(Assessed within the first 24 hours after birth.)
  • Birth Weight(Assessed at birth.)

研究者

发起方
Tepecik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Yıldırım

Obstetrics and Gynecology Specialist, Principal Investigator

Tepecik Training and Research Hospital

研究点 (1)

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