Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:26 AM
Study NCT ID:
NCT07310602
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dim Light During Labor on Pain, Anxiety, and Labor Progress
Sponsor:
Pınar Erdoğan
Organization:
Study Overview
Official Title:
The Effects of Dim Light (≤80 Lux) Exposure During Labor on Pain, Anxiety, and Labor Progress: A Single-Center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIM-LIGHT
Brief Summary:
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.
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.
Detailed Description:
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. Participants are allocated to one of two study groups according to a predefined randomization scheme. To minimize contamination between groups, cluster randomization by delivery room and week is applied.
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.
The dim light intervention is non-invasive and does not interfere with routine obstetric care. For clinical or safety reasons, room lighting can be increased immediately at any time at the discretion of the clinical team. All participants receive standard intrapartum care according to institutional protocols.
Study data are collected prospectively and stored in an anonymized format to ensure participant confidentiality. The study is conducted in accordance with ethical principles and has received approval from the relevant institutional ethics committee.
Eligible participants are women aged 18-45 years with a singleton, vertex-presenting pregnancy at ≥37 weeks of gestation who are in active labor. Participants are allocated to one of two study groups according to a predefined randomization scheme. To minimize contamination between groups, cluster randomization by delivery room and week is applied.
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.
The dim light intervention is non-invasive and does not interfere with routine obstetric care. For clinical or safety reasons, room lighting can be increased immediately at any time at the discretion of the clinical team. All participants receive standard intrapartum care according to institutional protocols.
Study data are collected prospectively and stored in an anonymized format to ensure participant confidentiality. The study is conducted in accordance with ethical principles and has received approval from the relevant institutional ethics committee.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: