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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two parallel study groups. To reduce contamination between groups, cluster randomization by delivery room and study week is applied.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity over time (VAS-AUC, 0-120 minutes)', 'timeFrame': 'From baseline to 120 minutes during active labor', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Anxiety level (STAI-S change)', 'timeFrame': 'From baseline to 90 minutes during active labor', 'description': 'State anxiety will be assessed using the State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S) at baseline (prior to intervention/exposure) and at 90 minutes during active labor. The STAI-S consists of 20 items, with total scores ranging from 20 to 80. Higher STAI-S scores indicate greater state anxiety (worse outcome). The primary analysis will use the change score (90-minute STAI-S minus baseline STAI-S); negative values indicate a reduction in anxiety.'}, {'measure': 'Oxytocin use (initiation rate and total dose)', 'timeFrame': 'During labor until delivery', 'description': 'Proportion of participants who receive oxytocin augmentation and the total oxytocin dose administered during labor will be recorded from clinical charts.'}, {'measure': 'Duration of active phase of labor', 'timeFrame': 'From enrollment to full dilation', 'description': 'Time from enrollment during active labor to full cervical dilation will be recorded.'}, {'measure': 'Duration of second stage of labor', 'timeFrame': 'From full dilation to delivery', 'description': 'Time from full cervical dilation to delivery will be recorded.'}, {'measure': 'Mode of delivery', 'timeFrame': 'At delivery', 'description': 'Vaginal delivery (spontaneous/assisted) and cesarean delivery will be recorded.'}, {'measure': 'Estimated blood loss', 'timeFrame': 'At delivery / immediate postpartum', 'description': 'Estimated maternal blood loss at delivery will be recorded from clinical records.'}, {'measure': 'Neonatal outcomes (Apgar scores)', 'timeFrame': '1 and 5 minutes after birth', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dim light', 'Lighting intensity', 'Labor room environment', 'Labor pain', 'Anxiety during labor', 'Childbirth', 'Intrapartum care', 'Non-pharmacological intervention'], 'conditions': ['Labor Pain and Anxiety', 'Labor Progress']}, 'referencesModule': {'references': [{'pmid': '32563747', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30670709', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Balabanoff D. Color, light, and birth space design: An integrative review. Color Res Appl. 2023;48:413-32. doi: 10.1002/COL.22842'}, {'pmid': '36915051', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '26834435', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nPain 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.\n\nThe 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.', 'detailedDescription': '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.\n\nEligible 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.\n\nIn 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.\n\nPain 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.\n\nThe 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.\n\nThe 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant individuals aged 18-45 years\n\nSingleton pregnancy\n\nVertex (cephalic) presentation\n\nGestational age ≥37 weeks\n\nActive labor at enrollment (cervical dilation between 4 and 8 cm)\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\nPlanned or ongoing epidural analgesia\n\nMultiple pregnancy\n\nSevere preeclampsia or other obstetric complications requiring immediate intervention\n\nKnown photosensitivity or light-related sensitivity disorders\n\nHistory of psychiatric disorders that may interfere with anxiety assessment\n\nAny condition deemed by the clinical team to require deviation from the study protocol'}, 'identificationModule': {'nctId': 'NCT07310602', 'acronym': 'DIM-LIGHT', 'briefTitle': 'Effects of Dim Light During Labor on Pain, Anxiety, and Labor Progress', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'The Effects of Dim Light (≤80 Lux) Exposure During Labor on Pain, Anxiety, and Labor Progress: A Single-Center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025/131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dim Light (50-80 Lux)', 'description': '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.', 'interventionNames': ['Other: Dim Light Exposure During Labor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Lighting (Control)', 'description': 'Routine labor room lighting will be maintained according to standard clinical practice. Standard intrapartum care will be provided.', 'interventionNames': ['Other: Routine Labor Room Lighting']}], 'interventions': [{'name': 'Dim Light Exposure During Labor', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Dim Light (50-80 Lux)']}, {'name': 'Routine Labor Room Lighting', 'type': 'OTHER', 'description': 'Standard labor room lighting conditions maintained according to routine clinical practice, without modification of illumination levels.', 'armGroupLabels': ['Routine Lighting (Control)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niğde', 'state': 'Niğde Province', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Pınar Erdoğan, Assoc. Prof.', 'role': 'CONTACT', 'email': 'pinar.erdogan@ohu.edu.tr', 'phone': '05233646954'}], 'facility': 'Niğde Ömer Halisdemir University Hospital', 'geoPoint': {'lat': 37.96583, 'lon': 34.67935}}], 'centralContacts': [{'name': 'Pınar Erdoğan, Assoc. Prof.', 'role': 'CONTACT', 'email': 'pinar.erdogan@ohu.edu.tr', 'phone': '+905233646954'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pınar Erdoğan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Assoc. Prof.', 'investigatorFullName': 'Pınar Erdoğan', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}