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临床试验/NCT07310602
NCT07310602已完成不适用

The Effects of Dim Light (≤80 Lux) Exposure During Labor on Pain, Anxiety, and Labor Progress: A Single-Center Randomized Controlled Trial

Pınar Erdoğan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Pain intensity over time (VAS-AUC, 0-120 minutes)

研究概览

简要总结

The environment of the labor room may influence how women experience childbirth. Light levels, in particular, may affect comfort, stress, and the course of labor. However, there is limited high-quality evidence on whether keeping the labor room lighting dim has measurable benefits for mothers.

This study aims to evaluate the effects of dim light exposure during active labor on pain, anxiety, and labor progress. Pregnant women who are in active labor at term will be randomly assigned to one of two groups. One group will give birth in a room with dim lighting (50-80 lux), while the other group will receive standard room lighting as part of routine care.

Pain and anxiety levels will be measured at specific time points during labor using standard assessment scales. Information about labor duration, use of labor medications, mode of delivery, and newborn outcomes will also be collected.

The dim light intervention does not interfere with routine obstetric care and does not pose additional risk to the mother or baby. If needed for clinical reasons, room lighting can be increased immediately. The results of this study may help determine whether a simple change in the birth environment can improve maternal comfort and labor outcomes.

详细描述

This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of dim light exposure during active labor on maternal pain, anxiety, and labor progress. The trial is conducted in a university hospital labor ward and includes term pregnant women in active labor.

Eligible participants are women aged 18-45 years with a singleton, vertex-presenting pregnancy at ≥37 weeks of gestation who are in active labor. Eligible participants are individually randomized in a 1:1 ratio to either the dim-light intervention group or the standard-light control group using a predefined randomization sequence. Randomization is performed at the participant level after confirmation of eligibility and informed consent.

In the intervention group, labor room lighting is adjusted to a dim light environment with an illumination level maintained between 50 and 80 lux, using warm white or amber light sources. Light intensity is monitored at regular intervals using a lux meter. In the control group, routine labor room lighting conditions are maintained in accordance with standard clinical practice.

Pain intensity and anxiety levels are assessed at predefined time points during labor using validated measurement tools. Labor progress and obstetric outcomes, including use of labor augmentation, duration of labor stages, mode of delivery, and neonatal outcomes, are recorded from clinical charts.

The primary outcome is derived from changes in pain intensity over time during labor. Secondary outcomes include anxiety levels, labor characteristics, and maternal and neonatal clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant individuals aged 18-45 years
  • Singleton pregnancy
  • Vertex (cephalic) presentation
  • Gestational age ≥37 weeks
  • Active labor at enrollment (cervical dilation between 4 and 8 cm)
  • Ability to provide written informed consent

排除标准

  • Planned or ongoing epidural analgesia
  • Multiple pregnancy
  • Severe preeclampsia or other obstetric complications requiring immediate intervention
  • Known photosensitivity or light-related sensitivity disorders
  • History of psychiatric disorders that may interfere with anxiety assessment
  • Any condition deemed by the clinical team to require deviation from the study protocol

研究组 & 干预措施

Dim Light (50-80 Lux)

Experimental

Labor room lighting will be maintained at 50-80 lux using warm white/amber light sources. Illumination will be monitored at regular intervals with a lux meter. Standard intrapartum care will be provided; lighting may be increased immediately if clinically needed.

干预措施: Dim Light Exposure During Labor (Other)

Routine Lighting (Control)

Active Comparator

Routine labor room lighting will be maintained according to standard clinical practice. Standard intrapartum care will be provided.

干预措施: Routine Labor Room Lighting (Other)

结局指标

主要结局

Pain intensity over time (VAS-AUC, 0-120 minutes)

时间窗: From baseline to 120 minutes during active labor

Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) at baseline (0 minutes), 60 minutes, and 120 minutes after allocation. The area under the curve (AUC) for VAS from 0 to 120 minutes will be calculated as the primary outcome.

次要结局

  • Duration of second stage of labor(From full dilation to delivery)
  • Estimated blood loss(At delivery / immediate postpartum)
  • Anxiety level (STAI-S change)(From baseline to 90 minutes during active labor)
  • Oxytocin use (initiation rate and total dose)(During labor until delivery)
  • Duration of active phase of labor(From enrollment to full dilation)
  • Neonatal outcomes (Apgar scores)(1 and 5 minutes after birth)
  • Anxiety level (STAI-S change)(From baseline to 90 minutes during active labor)
  • Duration of active phase of labor(From enrollment to full dilation)
  • Mode of delivery(At delivery)
  • Oxytocin use (initiation rate and total dose)(During labor until delivery)
  • Duration of second stage of labor(From full dilation to delivery)
  • Estimated blood loss(At delivery / immediate postpartum)
  • Neonatal outcomes (Apgar scores)(1 and 5 minutes after birth)

研究者

发起方
Pınar Erdoğan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pınar Erdoğan

MD, Assoc. Prof.

Nigde Omer Halisdemir University

研究点 (2)

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