진통, 불안 및 진통 진행에 대한 분만 중 희미한 조명의 영향 (DIM-LIGHT)
분만 중 약한 조명(≤80럭스) 노출이 통증, 불안 및 분만 진행에 미치는 영향: 단일 기관 무작위 대조 시험
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.
연구 개요
상세 설명
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.
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Niğde Province
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Niğde, Niğde Province, 터키 (Türkiye)
- Niğde Ömer Halisdemir University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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
Exclusion Criteria:
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Dim Light (50-80 Lux)
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. |
Adjustment of labor room illumination to a target range of 50-80 lux during active labor, with monitoring using a lux meter; lighting can be increased at any time for clinical reasons. |
|
활성 비교기: Routine Lighting (Control)
Routine labor room lighting will be maintained according to standard clinical practice. Standard intrapartum care will be provided. |
Standard labor room lighting conditions maintained according to routine clinical practice, without modification of illumination levels. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity over time (VAS-AUC, 0-120 minutes)
기간: From baseline to 120 minutes during active labor
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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. |
From baseline to 120 minutes during active labor
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anxiety level (six-item short-form state anxiety score)
기간: From baseline to 90 minutes during active labor
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State anxiety was assessed at baseline (prior to intervention/exposure) and at 90 minutes during active labor using a six-item short form derived from the State scale of the State-Trait Anxiety Inventory (STAI). Each item was rated on a four-point scale, with positively worded items reverse-scored. Item scores were summed to yield a raw total score ranging from 6 to 24, with higher scores indicating greater state anxiety. The between-group difference in anxiety at 90 minutes was evaluated with adjustment for baseline anxiety score. |
From baseline to 90 minutes during active labor
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Oxytocin use (initiation rate and total dose)
기간: During labor until delivery
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Proportion of participants who receive oxytocin augmentation and the total oxytocin dose administered during labor will be recorded from clinical charts. |
During labor until delivery
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Duration of active phase of labor
기간: From enrollment to full dilation
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Time from enrollment during active labor to full cervical dilation will be recorded. |
From enrollment to full dilation
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Duration of second stage of labor
기간: From full dilation to delivery
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Time from full cervical dilation to delivery will be recorded. |
From full dilation to delivery
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Mode of delivery
기간: At delivery
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Vaginal delivery (spontaneous/assisted) and cesarean delivery will be recorded. |
At delivery
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Estimated blood loss
기간: At delivery / immediate postpartum
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Estimated maternal blood loss at delivery will be recorded from clinical records. |
At delivery / immediate postpartum
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Neonatal outcomes (Apgar scores)
기간: 1 and 5 minutes after birth
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Neonatal well-being will be assessed using the Apgar scoring system at 1 and 5 minutes after birth. The Apgar score ranges from 0 to 10, based on five components (heart rate, respiratory effort, muscle tone, reflex irritability, and skin color). Higher Apgar scores indicate better neonatal condition (better outcome). Apgar scores at 1 and 5 minutes will be recorded and analyzed descriptively. |
1 and 5 minutes after birth
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Buckley SJ. Executive Summary of Hormonal Physiology of Childbearing: Evidence and Implications for Women, Babies, and Maternity Care. J Perinat Educ. 2015;24(3):145-53. doi: 10.1891/1058-1243.24.3.145.
- Zsido AN, Teleki SA, Csokasi K, Rozsa S, Bandi SA. Development of the short version of the spielberger state-trait anxiety inventory. Psychiatry Res. 2020 Sep;291:113223. doi: 10.1016/j.psychres.2020.113223. Epub 2020 Jun 12.
- Wronding T, Argyraki A, Petersen JF, Topsoe MF, Petersen PM, Lokkegaard ECL. The aesthetic nature of the birthing room environment may alter the need for obstetrical interventions - an observational retrospective cohort study. Sci Rep. 2019 Jan 22;9(1):303. doi: 10.1038/s41598-018-36416-x.
- Balabanoff D. Color, light, and birth space design: An integrative review. Color Res Appl. 2023;48:413-32. doi: 10.1002/COL.22842
- Kazemi A, Beigi M, Najafabadi HE. Environmental factors influencing women's childbirth experiences in labor-delivery-recovery-postpartum unit: a qualitative cross-sectional study. BMC Pregnancy Childbirth. 2023 Mar 13;23(1):169. doi: 10.1186/s12884-023-05488-7.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025/131
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared due to the sensitive nature of intrapartum clinical data and the absence of participant consent for data sharing beyond the objectives of this study. De-identified aggregate results will be reported through publications.
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