Use of Low-Intensity Laser Therapy to aid in the healing of injuries in the genital (vaginal) region: a randomized clinical trial

INTERVENTION: This is a pilot study, designed as a randomized, controlled, parallel clinical trial, with blinding of the evaluator, volunteers, and students, conducted at a public hospital in the southern zone of São Paulo. Postpartum women =18 years of age who underwent vaginal delivery with perineal trauma will be randomized into two groups: the Experimental Group, which will receive Low‐Intensity Laser (LIL) associated with conventional care, and the Control Group, which will receive placebo LIL associated with the same care. The sample will consist of 160 postpartum women (80 per group), defined by sample calculation with 80% power and 95% confidence level. Randomization will be performed by computer sequence, with confidentiality ensured by opaque and sealed envelopes. The interventions will occur in two sessions (up to 2 hours postpartum and between 40–48 hours), using simultaneous red and infrared light in the EG, while the CG will receive a placebo application. Data collection will occur at three times: up to 2 hours after delivery, between 40–48 hours, and between 8–12 days postpartum. Outcomes such as healing, pain, and satisfaction will be assessed using the REEDA, END, and Likert scales, in addition to the use of analgesics as a secondary outcome. The study will follow CONSORT guidelines to ensure methodological quality and transparency. CONDITION: A01.719 Episiotomy; Rupture, Spontaneous ; Perineum PRIMARY OUTCOME: To evaluate the effectiveness of low‐level laser therapy (LLLT) in accelerating the healing process in women with perineal trauma following vaginal delivery. To evaluate the effectiveness of low‐level laser therapy (LLLT) in reducing pain in women with perineal trauma following vaginal delivery.; SECONDARY OUTCOME: Describe in detail the LBI application protocol used in the experimental group, including the technical parameters (wavelength, power, energy density, application mode, time per spot, number of spots) and the frequency of sessions To analyze the potential impact of perineal pain on the daily activities of postpartum women (such as sitting, walking, and caring for the baby) and on the breastfeeding process, by comparing the reports across the groups To assess and compare the incidence of local complications, such as signs of infection (excessive redness, purulent discharge, foul odor) and suture dehiscence, between the two groups during the follow‐up period To assess and compare the intensity of perineal pain reported by the participants, using a Numerical Pain Scale, between the experimental and control groups at the same postpartum assessment time points To compare the progression of perineal healing, assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation), between the group receiving the LLLT intervention (experimental group) and the group receiving the placebo intervention (control group), LLLT will be applied immediately postpartum, up to 2 (two) hours postpartum, and between 40 and 48 hours postpartum INCLUSION CRITERIA: The study will include only women; aged 18 years or older; who have had a vaginal delivery (natural or forceps) involving perineal trauma; who are clinically stable in the immediate postpartum period; who are literate and able to understand and respond to the data collection instruments; Agree to participate in the study and sign the Informed Consent Form (ICF)