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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Labor Progression
• Intervention / Treatment: Other: No Intervention: Observational Cohort

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.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35020
    • Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study population consists of term primiparous pregnant women who attended routine antenatal follow-up at Izmir Tepecik Training and Research Hospital and subsequently experienced spontaneous onset of labor. All participants were healthy, low-risk obstetric patients with singleton, cephalic presentations and no medical or obstetric complications.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primiparous Cohort; Term primiparous women assessed for sleep quality, anxiety, digital behavior, and followed through spontaneous labor.	Other: No Intervention: Observational Cohort; Observational study with no assigned treatment or intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Active Labor	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.	From onset of active labor (≥4 cm) until full cervical dilatation (10 cm), typically within 2 to 12 hours.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Sleep Quality; Childbirth; Primiparous Women; Digital Behavior; Oxytocin Augmentation
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Anxiety Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: TEPECIK-SAD-LABOR; TEPECIK-EC-2025-07-10 (06/08/2 (Registry Identifier: İzmir Tepecik Training and Research Hospital Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The dataset contains sensitive clinical information from pregnant women and cannot be made publicly available due to institutional and national data protection regulations. Summary results will be published in peer-reviewed journals, but no individual-level data will be released.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No