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

NCT ID: NCT07299708

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2025-11-30

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.

Conditions

Labor Progression; Pregnancy

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primiparous Cohort

Term primiparous women assessed for sleep quality, anxiety, digital behavior, and followed through spontaneous labor.

No Intervention: Observational Cohort

Intervention Type: OTHER

Observational study with no assigned treatment or intervention.

Interventions

No Intervention: Observational Cohort

Observational study with no assigned treatment or intervention.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tepecik Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fatih Yıldırım

Obstetrics and Gynecology Specialist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tepecik Training and Research Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TEPECIK-EC-2025-07-10 (06/08/2

Identifier Type: REGISTRY

Identifier Source: secondary_id

TEPECIK-SAD-LABOR

Identifier Type: -

Identifier Source: org_study_id