ClinicalTrials.gg
CompletedNCT07299708SAD-LABORUpdated Dec 23, 2025

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

An observational study in Labor Progression and Pregnancy, sponsored by Tepecik Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Tepecik Training and Research Hospital · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
127
Ages
18 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey — 97 open to participants now, 110 under way, none of them phase 3. Sleep Initiation and Maintenance Disorders · Turkey.

Enrollment
36th of 81
127 · median 120
Started
2025
with 91 others
Observational
81 of 391
22 open now
Registered
275th of 391
by date

Among the 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey, this one is the 36th largest by enrollment of the 81 observational ones that give a count, is one of 92 that started in 2025, is one of 81 observational ones, and was the 275th registered.

Sleep Initiation and Maintenance Disorders

2,726 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 728 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Open to participants now

97 of the 391 studies in Sleep Initiation and Maintenance Disorders with a site in Turkey are open now. Recruiting first, the newest first:

92 more — sign in →

All 97 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 388 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 206 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.

This study: 18 Years to 50 Years · female · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Labor Progression
  • Pregnancy

Keywords

  • Sleep Quality
  • Anxiety
  • Digital Behavior
  • Primiparous Women
  • Childbirth
  • Oxytocin Augmentation
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
127 participants (actual)
Patient registry
No

Groups and cohorts

  • Primiparous Cohort

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

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    Observational study with no assigned treatment or intervention.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

    Time frame: From onset of regular contractions until onset of active labor (≥4 cm), typically lasting up to 20 hours.

  2. 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.

    Time frame: From full dilatation (10 cm) until birth, typically lasting up to 3 hours.

  3. Oxytocin Augmentation Requirement

    Proportion of participants requiring oxytocin infusion due to inadequate uterine contractions or labor arrest, as documented by obstetric staff.

    Time frame: From admission in active labor (≥4 cm) until delivery, typically within 2 to 12 hours.

  4. Mode of Delivery

    Rates of spontaneous vaginal delivery, operative vaginal delivery, and cesarean delivery, evaluated according to sleep, anxiety, and digital behavior parameters.

    Time frame: Assessed at delivery.

  5. 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.

    Time frame: From onset of active labor (≥4 cm) until delivery, typically within 2 to 12 hours.

  6. APGAR Score at 1 and 5 Minutes

    Apgar scores assessed at 1 and 5 minutes after birth.

    Time frame: Assessed at 1 and 5 minutes after birth.

  7. Neonatal Intensive Care Unit (NICU) Admission

    Number of neonates requiring admission to the neonatal intensive care unit.

    Time frame: Assessed within the first 24 hours after birth.

  8. Birth Weight

    Neonatal birth weight measured in grams immediately after delivery.

    Time frame: Assessed at birth.

07

Study locations

1 site
  • Tepecik Training and Research Hospital
    Izmir, 35020, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2025 to primary completion in Nov 2025, 3 months.

Of 127 non-industry observational studies under Sleep Initiation and Maintenance Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 42. This study's 3 months is below that.

Counting every sponsor, half of 137 studies reached it within 18 months; a quarter within 4 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2025
First posted
Dec 23, 2025
StartActual
Aug 10, 2025
Primary completionActual
Nov 25, 2025
CompletionActual
Nov 30, 2025
Last update
Dec 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07299708
Lead sponsor
Tepecik Training and Research Hospital
Responsible party
Fatih Yıldırım (Obstetrics and Gynecology Specialist, Principal Investigator, Tepecik Training and Research Hospital) — Principal investigator
First posted
Dec 23, 2025
Start date
Aug 10, 2025
Primary completion
Nov 25, 2025
Completion
Nov 30, 2025
Last update
Dec 23, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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