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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07299708
Acronym
SAD-LABOR
Enrollment
127
Registered
2025-12-23
Start date
2025-08-10
Completion date
2025-11-30
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Progression, Pregnancy

Keywords

Sleep Quality, Anxiety, Digital Behavior, Primiparous Women, Childbirth, Oxytocin Augmentation

Brief summary

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.

Detailed description

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.

Interventions

OTHERNo Intervention: Observational Cohort

Observational study with no assigned treatment or intervention.

Sponsors

Tepecik Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Duration of Active LaborFrom 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.

Secondary

MeasureTime frameDescription
Duration of Second Stage of LaborFrom full dilatation (10 cm) until birth, typically lasting up to 3 hours.Time in minutes from full cervical dilatation (10 cm) to the delivery of the neonate. Pushing time will be recorded prospectively.
Oxytocin Augmentation RequirementFrom admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.Proportion of participants requiring oxytocin infusion due to inadequate uterine contractions or labor arrest, as documented by obstetric staff.
Mode of DeliveryAssessed at delivery.Rates of spontaneous vaginal delivery, operative vaginal delivery, and cesarean delivery, evaluated according to sleep, anxiety, and digital behavior parameters.
Duration of Latent Phase of LaborFrom onset of regular contractions until onset of active labor (≥4 cm), typically lasting up to 20 hours.Time (in minutes) from onset of regular contractions to 4 cm cervical dilation, recorded prospectively from labor charts. Evaluated in relation to sleep quality, anxiety levels, and nighttime digital behavior.
APGAR Score at 1 and 5 MinutesAssessed at 1 and 5 minutes after birth.Apgar scores assessed at 1 and 5 minutes after birth.
Neonatal Intensive Care Unit (NICU) AdmissionAssessed within the first 24 hours after birth.Number of neonates requiring admission to the neonatal intensive care unit.
Birth WeightAssessed at birth.Neonatal birth weight measured in grams immediately after delivery.
Use of Epidural AnalgesiaFrom onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.Proportion of participants receiving epidural anesthesia for labor pain management, and its association with sleep quality, anxiety scores, and digital device use.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026