protocolSection identificationModule nctId: NCT06370910, orgStudyIdInfo id: CAAE 58569421.5.0000.5327, briefTitle: Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction, acronym: CL, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-05, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Federal University of Rio Grande do Sul, class: OTHER, descriptionModule briefSummary: The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery., conditionsModule conditions: Episiotomy; Complications, conditions: Laceration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Low-Level Laser Therapy, outcomesModule primaryOutcomes measure: To compare two techniques: Low-level laser and cryotherapy, secondaryOutcomes measure: Pain reduction assessed by the Visual Analog Scale (VAS)., secondaryOutcomes measure: Pain reduction assessed by McGill Pain Scale, secondaryOutcomes measure: Evaluate reduction of swelling using the REEDA scale., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital de Clínicas de Porto Alegre, city: Porto Alegre, zip: RS, country: Brazil, geoPoint lat: -30.03306, lon: -51.23, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-04, uploadDate: 2024-04-12T18:23, filename: Prot_SAP_000.pdf, size: 47665, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-04, uploadDate: 2024-04-12T18:21, filename: ICF_001.pdf, size: 66023, hasResults: False