Efectos de la Luz Tenue Durante el Parto en el Dolor, la Ansiedad y el Progreso del Parto (DIM-LIGHT)
Los Efectos de la Exposición a Luz Tenue (≤80 Lux) Durante el Parto en el Dolor, la Ansiedad y el Progreso del Parto: Un Ensayo Controlado Aleatorizado de un Solo Centro
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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Niğde Province
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Niğde, Niğde Province, Turquía (Türkiye)
- Niğde Ömer Halisdemir University Hospital
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 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. |
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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity over time (VAS-AUC, 0-120 minutes)
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anxiety level (six-item short-form state anxiety score)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2025/131
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
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