[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659375":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":48,"studyPopulation":36,"armGroups":49,"interventions":62,"overallOfficials":36,"centralContacts":78,"locations":84,"responsibleParty":113,"collaborators":36,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":36,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":87,"whyStopped":36,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Universidad Nacional Autonoma de Honduras","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative Pain Intensity at rest at 24 Hours","Measured using the Visual Analog Scale (VAS) for pain ranging from 0 (no pain) to 10 (worst imaginable pain) while the participant is at complete rest (supine or semi-recumbent position, without movement or coughing) at 24 hours post-cesarean delivery.","24 hours post-surgery",[14,18,22,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Postoperative Pain Intensity at Rest at 48 Hours","Measured using the Visual Analog Scale (VAS) for pain ranging from 0 (no pain) to 10 (worst imaginable pain) while the participant is at complete rest (supine or semi-recumbent position) at 48 hours post-cesarean delivery.","48 hours post-surgery",{"measure":19,"description":20,"timeFrame":21},"Cumulative Rescue Analgesic Consumption","Total cumulative dose of rescue NSAIDs and opioids administered during the first 48 hours post-surgery to control breakthrough pain at rest, expressed as total milligrams and number of rescue doses required.","First 48 hours post-surgery",{"measure":23,"description":24,"timeFrame":17},"Surgical Wound Healing Assessment (REEDA Scale)","Clinical evaluation of the abdominal wound using the REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Total score ranges from 0 to 15, with lower scores indicating better wound healing",{"measure":26,"description":27,"timeFrame":28},"Time to First Effective Ambulation","Time elapsed from the completion of cesarean surgery to the participant's first autonomous unassisted ambulation (walking at least 5 steps), measured in hours","Up to 48 hours post-surgery",{"measure":30,"description":31,"timeFrame":32},"Maternal Childbirth Experience and Satisfaction (CEQ2)","Maternal satisfaction with pain management and overall childbirth experience evaluated at hospital discharge using the Childbirth Experience Questionnaire version 2 (CEQ2)","At hospital discharge (approximately 48 hours post-surgery)",{"measure":34,"description":35,"timeFrame":28},"Incidence of Treatment-Emergent Adverse Events","Frequency, severity, and causality of local adverse events (eruthema, skin irritation, thermal discomfort, burns) and systemic adverse events recorded during the trial",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","This is a prospective, single-center, randomized, double-blind, sham-controlled, 2-arm parallel-group superiority clinical trial. Eligible postpartum women undergoing cesarean section are randomized in a 1:1 allocation ratio to receive either active photobiomodulation (MitoQUAD® Belt) or an inactive sham device, as an adjunct to standard multimodal analgesia. Randomization is generated using REDCap® central randomization software with permuted block sizes to guarantee allocation concealment. Participants in both arms receive three 15-minute device applications (at 30 minutes, 24 hours, and 36-48 hours post-cesarean). Quadruple masking is strictly enforced: participants, attending clinical staff, investigators, and outcome assessors are fully blinded to treatment allocation. The sham device is physically identical to the active unit in size, shape, weight, display, and operation.","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":45},"DOUBLE","The active MitoQUAD® device and the sham device are physically identical in size, shape, weight, color, sound emissions, and user interface. The sham device delivers no therapeutic light energy. Allocation concealment is managed through unique device codes via REDCap®.",[46,47],"PARTICIPANT","OUTCOMES_ASSESSOR","Cesarean delivery is associated with significant postoperative pain originating from both somatic abdominal wall trauma and visceral uterine traction. Standard pharmacologic management relies heavily on NSAIDs, acetaminophen, and opioids; however, opioids carry risks of sedation, nausea, constipation, and potential neonatal exposure via breastfeeding. Photobiomodulation (PBM) uses low-level light in red (630-660 nm) and near-infrared (810-850 nm) spectrums to activate mitochondrial cytochrome c oxidase, boosting ATP synthesis, modulating inflammatory cytokines (TNF-α, IL-1β, IL-6), and accelerating collagen synthesis and re-epithelialization. This single-center, randomized, double-blind, sham-controlled, parallel-group, superiority trial will enroll 210 postpartum women aged 18-40 undergoing elective or emergency cesarean delivery via Pfannenstiel incision under neuraxial anesthesia at Hospital Escuela in Tegucigalpa, Honduras. Eligible participants who provide written informed consent will be randomized 1:1 via REDCap® central randomization into two groups:Active PBM Group (n=105): Receives three 15-minute applications of the MitoQUAD® Belt device (emitting 630 nm, 660 nm, 810 nm, and 850 nm at 13.28 mW\u002Fcm²) placed over a sterile transparent dressing covering the surgical wound. Sham Control Group (n=105): Receives three 15-minute applications of an inactive sham device identical in physical appearance, timer display, and user operation. Application Schedule: Session 1 at 30 minutes post-surgery; Session 2 at 24 hours; Session 3 between 36-48 hours post-surgery. Both groups receive identical institutional multimodal analgesia. Primary outcome is pain intensity during movement at 24 hours post-surgery measured via Visual Analog Scale (VAS 0-10). Secondary outcomes include VAS pain at rest (24h, 48h) and movement (48h), cumulative rescue analgesic consumption (mg and doses), wound healing evaluated by the REEDA scale at 48 hours, time to first autonomous ambulation (hours), maternal childbirth experience evaluated by the CEQ2 questionnaire at discharge, and safety outcomes. Analyses will follow the Intention-To-Treat (ITT) principle.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Active Photobiomodulation","EXPERIMENTAL","Participants receive active photobiomodulation therapy using the MitoQUAD® Belt device placed over a sterile transparent dressing covering the Pfannenstiel surgical incision. Treatment consists of three 15-minute sessions applied at 30 minutes post-surgery, 24 hours post-surgery, and between 36-48 hours post-surgery, in addition to standard multimodal analgesia.",[55],"Device: Photobiomodulation Therapy (MitoQUAD® Belt System)",{"label":57,"type":58,"description":59,"interventionNames":60},"Sham Device Control","SHAM_COMPARATOR","Participants receive a sham intervention using a inactive device externally identical in appearance, weight, dimensions, and operational interface to the active device. The sham device is applied over the surgical incision on the same 3-session schedule (15 minutes each at 30 min, 24 h, and 36-48 h post-cesarean), in addition to standard multimodal analgesia.",[61],"Device: Sham Photobiomodulation Device",[63,72],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"DEVICE","Photobiomodulation Therapy (MitoQUAD® Belt System)","The Sham Photobiomodulation Device is an inactive placebo unit designed to serve as a control intervention. It is physically identical to the active MitoQUAD® Belt system in appearance, size, shape, weight, color, timer display, audible signals, and user operation, but delivers no therapeutic red or near-infrared light energy. The sham device is applied transcutaneously over a sterile transparent dressing covering the Pfannenstiel surgical wound using the exact same treatment schedule:Session 1: Applied approximately 30 minutes post-cesarean delivery. Session 2: Applied at 24 hours post-surgery. Session 3: Applied between 36 and 48 hours post-surgery. Each session lasts 15 minutes. Participants in this control arm receive identical standard institutional post-cesarean multimodal analgesia. Application procedures, duration, and patient positioning are indistinguishable from the experimental group to maintain study blinding.",[51],[69,70,71],"Low-Level Light Therapy (LLLT)","MitoQUAD Belt","Red and Near-Infrared LED Therapy",{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Sham Photobiomodulation Device","The Sham Photobiomodulation Device is an inactive placebo unit designed to serve as a control intervention. It is physically identical to the active MitoQUAD® Belt system in appearance, size, shape, weight, color, timer display, audible signals, and user operation, but delivers no therapeutic red or near-infrared light energy.\n\nThe sham device is applied transcutaneously over a sterile transparent dressing covering the Pfannenstiel surgical wound using the exact same treatment schedule:\n\nSession 1: Applied approximately 30 minutes post-cesarean delivery.\n\nSession 2: Applied at 24 hours post-surgery.\n\nSession 3: Applied between 36 and 48 hours post-surgery.\n\nEach session lasts 15 minutes. Participants in this control arm receive identical standard institutional post-cesarean multimodal analgesia. Application procedures, duration, and patient positioning are indistinguishable from the experimental group to maintain study blinding.",[57],[77],"Inactive Placebo Light Therapy Device",[79],{"name":80,"role":81,"phone":82,"phoneExt":36,"email":83},"Ricardo A. Gutierrez-Ramirez, MD, MSc","CONTACT","97546940","ricardo.gutierrez@unah.edu.hn",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":36,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Hospital Escuela","RECRUITING","Tegucigalpa","Francisco Morazán Department","Honduras","HN",{"type":93,"coordinates":94},"Point",[95,96],-87.20681,14.0818,{"lat":96,"lon":95},[99,101,104,106,108,111],{"name":100,"role":81,"phone":82,"phoneExt":36,"email":83},"Ricardo Arturo Gutierrez Ramirez, MD, MSc.",{"name":102,"role":103,"phone":36,"phoneExt":36,"email":36},"Maria F. Díaz Álvarez, MD","PRINCIPAL_INVESTIGATOR",{"name":105,"role":103,"phone":36,"phoneExt":36,"email":36},"Karen R. Ponce García, MD",{"name":107,"role":103,"phone":36,"phoneExt":36,"email":36},"Eliuth Y. Martínez López, MD",{"name":109,"role":110,"phone":36,"phoneExt":36,"email":36},"Ricardo A Gutierrez Ramirez, MD, MSc.","SUB_INVESTIGATOR",{"name":112,"role":110,"phone":36,"phoneExt":36,"email":36},"Silder J. Moncada Moncada, MD",{"type":103,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Ricardo A Gutierrez Ramirez, MD, MSc, FACOG","Research Coordinator","100659375","efficacy-and-safety-of-photobiomodulation-for-postoperative-pain-after-cesarean-section-100659375",false,"NCT07863960","Efficacy and Safety of Photobiomodulation for Postoperative Pain After Cesarean Section","Efficacy and Safety of Photobiomodulation on Postoperative Pain in Postpartum Women Undergoing Cesarean Section at Hospital Escuela and IHSS Tegucigalpa, Honduras: A Randomized, Double-Blind, Sham-Controlled Clinical Trial","BIOLUZCE","Inclusion Criteria:\n\n1. Provided written informed consent prior to any study-related procedure.\n2. Aged between 18 and 40 years at the time of enrollment.\n3. Singleton pregnancy with a gestational age between 37+0 and 41+6 weeks confirmed by first-trimester ultrasound or reliable last menstrual period.\n4. Single fetus in cephalic presentation.\n5. Scheduled or emergency primary or repeat low-transverse segment cesarean section (maximum 1 prior cesarean delivery) performed via Pfannenstiel incision.\n6. Received neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) according to institutional protocol.\n7. Skin closure executed using standardized technique (absorbable intradermal suture, nylon, or surgical staples).\n\nExclusion Criteria:\n\n1. Pregestational diabetes mellitus or gestational diabetes requiring insulin therapy or with inadequate glycemic control.\n2. Medical conditions affecting normal wound healing or inflammatory response (e.g., systemic lupus erythematosus, scleroderma, immunodeficiencies, or chronic systemic corticosteroid\u002Fimmunosuppressive therapy).\n3. Active chorioamnionitis, sepsis, active systemic infection, or pre-existing skin infection at the surgical site.\n4. Complicated cesarean delivery with operative time exceeding 90 minutes, surgical drain placement, or intraoperative organ injury.\n5. History of severe keloid formation or known abdominal hypertrophic scarring disorders.\n6. Chronic pain syndromes, fibromyalgia, chronic opioid use, or history of substance abuse.\n7. Intraoperative conversion to general anesthesia or failure of planned neuraxial anesthesia.\n8. Body Mass Index (BMI) ≥ 40 kg\u002Fm² at late pregnancy.\n9. Known hypersensitivity or allergy to materials used in the photobiomodulation device or dressing.\n10. Concurrent participation in another clinical trial or receipt of an investigational product within 30 days prior to enrollment.\n11. Any significant medical, obstetric, or psychiatric condition that, in the judgment of the Principal Investigator, could compromise participant safety or protocol compliance.",true,"FEMALE","18 Years","45 Years",{"count":129,"type":130},210,"ESTIMATED","INTERVENTIONAL",[133],"NA","Postoperative pain following cesarean section remains a major clinical challenge that can impair early maternal recovery, delay ambulation, and interfere with newborn care. Photobiomodulation (PBM) is a non-invasive light therapy that uses red and near-infrared light to reduce inflammation, stimulate cellular energy (ATP) production, and promote tissue repair. The purpose of this randomized, double-blind, sham-controlled clinical trial is to evaluate the efficacy and safety of portable photobiomodulation using the MitoQUAD® device as an adjunct to standard multimodal analgesia in postpartum women undergoing cesarean section. Participants (N=210) will be randomized (1:1) to receive either active PBM or a sham device in three 15-minute sessions (at 30 minutes, 24 hours, and 36-48 hours post-cesarean). Pain intensity, rescue analgesic use, wound healing, time to ambulation, maternal satisfaction, and adverse events will be monitored over 48 hours.",[136],"Postoperative Pain After Cesarean Section",[138,139,140,141,142],"Photobiomodulation","Low-Level Light Therapy","Postpartum Pain","Cesarean Delivery","Multimodal Analgesia","2026-10-01",{"date":145,"type":146},"2026-10-07","ACTUAL",{"date":143,"type":146},{"date":149,"type":130},"2027-02-01",{"name":5,"class":6},1]