[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591774":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":60,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":32,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Nove de Julho","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photobiomodulation Group","EXPERIMENTAL","All participants will undergo the same Intrauterine Device insertion procedure. For irradiation, a Light Emitting Diode panel from the brand Sportlux® (Brazil, SP) will be used, with the following specifications. Photobiomodulation in the experimental group will be administered using 132 Light Emitting Diodes, with 660 nm and 850 nm wavelengths, applied in contact mode. Each Light Emitting Diode has an emission area of 0.5 cm², with an application time of 20 minutes, an irradiance of 16 mW\u002Fcm², and an energy delivery of 4.8 J per Light Emitting Diode, resulting in a radiant exposure of 9.6 J\u002Fcm².",[13],"Device: Photobiomodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Simulation of Photobiomodulation Group","SHAM_COMPARATOR","All participants in this group will undergo the conventional Intrauterine Device insertion procedure, as previously described. They will receive a simulation of photobiomodulation and will be treated identically to the Experimental Group. The researcher responsible for the photobiomodulation application will simulate irradiation by positioning the device in the exact location as in the Experimental Group; however, the equipment will remain turned off.\n\nTo prevent participants from identifying the group to which they belong, the device's activation sound (beep) will be pre-recorded and played during the application.",[19],"Other: Simulation of Photobiomodulation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Photobiomodulation","The irradiated region will cover the lumbar and thoracic spine, specifically from T10 to L4, using the Light Emitting Diode panel in a vertical orientation. Photobiomodulation in the experimental group will be administered using 132 Light Emitting Diodes with wavelengths of 660 nm and 850 nm, applied in contact mode. Each Light Emitting Diode has an emission area of 0.5 cm², with an application time of 20 minutes, an irradiance of 16 mW\u002Fcm², and an energy delivery of 4.8 J per Light Emitting Diode, resulting in a radiant exposure of 9.6 J\u002Fcm².",[9],[27],"low level laser therapy",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Simulation of Photobiomodulation","The researcher responsible for the photobiomodulation application will simulate irradiation by positioning the device in the exact location as in the Photobiomodulation Group; however, the equipment will remain turned off.\n\nTo prevent participants from identifying the group to which they belong, the device's activation sound (beep) will be pre-recorded and played during the application.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Anna Carolina Nunes Ferraz","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"ANNA CAROLINA N FERRAZ, PhD student","CONTACT","11996324513","Anna Carolina Nunes Ferraz \u003Cannacarolina1984@gmail.com>",{"name":44,"role":40,"phone":45,"phoneExt":32,"email":46},"Anna Carolina Ratto Tempestini Horliana, PhD","11948002288","annacrth@gmail.com",[48],{"facility":49,"status":32,"city":50,"state":32,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":32},"Nove de Julho University (UNINOVE)","São Paulo","01504-001","Brazil","BR",{"type":55,"coordinates":56},"Point",[57,58],-46.63611,-23.5475,{"lat":58,"lon":57},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Anna Carolina Ratto Tempestini Horliana","Clinical Professor","100591774","photobiomodulation-on-pain-perception-during-the-insertion-of-the-t-380-copper-intrauterine-device-iud-100591774",false,"NCT06984796","Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)","Effect of Photobiomodulation on Reducing Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD) for Contraception: a Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* Women aged 18-50 years,\n* Female,\n* No preference regarding race or socioeconomic status,\n* Nulliparous or multiparous.\n\nExclusion Criteria:\n\n* Known or suspected pregnancy,\n* Diagnosed with chronic pain,\n* Active local infection,\n* Use of any pain medication in the last 12 hours,\n* Known contraindication for IUD insertion, including significant uterine cavity distortion, active pelvic inflammatory disease, or Wilson's disease,\n* Allergy to copper,\n* Unexplained abnormal uterine bleeding,\n* Any condition affecting the lumbar region, such as active neoplasms, established osteomyelitis, or any pre-existing deep tissue lesions with necrosis or infection,\n* History of photosensitivity.",true,"FEMALE","18 Years","50 Years",{"count":75,"type":76},72,"ESTIMATED","INTERVENTIONAL",[79],"NA","Unplanned pregnancy affects up to 65% of women in some regions of Brazil, contributing to unsafe abortions and maternal mortality. The copper IUD is an effective long-term contraceptive but is underused, with only 4.4% of women of reproductive age using it. One barrier is the pain during insertion, leading to low adherence. Photobiomodulation (PBM), which has anti-inflammatory and analgesic effects, may offer a solution. This study aims to assess PBM's efficacy as a preemptive analgesic during copper IUD insertion in a randomized, double-blind trial involving 72 participants. The experimental group (n=36) will receive active PBM, while the control group (n=36) will receive PBM simulation. Pain will be measured using the Visual Analog Scale (VAS) at multiple time points, and additional outcomes include analgesic use, quality of life (WHOQOL-100), anxiety (GAD-7), satisfaction, and adverse effects. Statistical analysis will include tests such as the Friedman test, logistic regression, and ANOVA, with a significance level of 5%.",[82],"Pain",[84,85],"intrauterine device","photobiomodulation","NOT_YET_RECRUITING","2026-02-03",{"date":89,"type":90},"2026-02-04","ACTUAL",{"date":92,"type":76},"2026-03-30",{"date":94,"type":76},"2027-05-30",{"name":5,"class":6},1]