Laser for pain relief in Nipple and Perineal Trauma in postpartum

INTERVENTION: E02.594.540 This is a two‐arm, double‐blind, randomized controlled clinical trial. The sample will consist of 120 participants. In the nipple trauma arm: lactating women between 6 and 12 hours after delivery who present nipple trauma and pain intensity 4 using the Visual Analogue Scale (30 in the experimental group; 30 in the control group). Randomization will be performed using computer software, followed by allocation with blinding. The experimental group will receive an application of 2 Joules of visible energy with a wavelength of 660 ± 10 nm at the trauma site and 3 Joules of infrared light with a wavelength of 808 ± 10 nm at four points around the areola, with a distance between the application points of 2 cm. The control group will receive a simulation of the therapy. The participant and the supervising researcher will not know the allocation, only the assistant who will apply the photobiomodulation will know. In the perineal injury arm: women between 6 and 12 hours after vaginal delivery, who present at least grade 2 perineal laceration or episiotomy and pain intensity 4 using the Visual Analogue Scale (30 in the experimental group; 30 in the control group ). Randomization will be performed using computer software, followed by allocation with blinding. The experimental group will receive an application on the lesion of 4 Joules of red light and 2 or 3 Joules of infrared light around the wound, being able to have an intravaginal application, with a distance between the points of 2 cm. The control group will receive a simulation of the therapy. The participant and the supervising researcher will not know the allocation, only the assistant who will apply the photobiomodulation will know. CONDITION: C12.050.703.844 Mastitis; Episiotomy; Lacerations; Pain. PRIMARY OUTCOME: In the perineal trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Short Form McGill Pain Questionnaire (observing a minimum reduction of 5 points in the Pain Index). Pain Rating; 1 point on the Present Pain Intensity Scale; and 1.37 cm on the Visual Analogue Scale) and the Numerical Pain Assessment Scale (observing a minimum reduction of 2 points).; ; In the nipple trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Visual Analogue Scale (observing a minimum reduction of 1.37 cm) and the Numerical Scale of Pain Assessment (observing a minimum reduction of 2 points). SECONDARY OUTCOME: In both arms, healing and satisfaction will be evaluated through a telephone interview, using a Likert scale, presenting the percentile of improvement in healing and satisfaction. INCLUSION CRITERIA: Inclusion criteria for the Nipple Trauma group: Older than 18 years; Who are breastfeeding and have nipple trauma; Present understanding of the Portuguese language and cognitive ability to consent; Reporting nipple pain of at least 4 (four) on the visual analogue scale (VAS) at the time of approach. Inclusion criteria for the Perineal Trauma group: Older than 18 years; Who have perineal injuries resulting from childbirth (episiotomy or 2nd‐degree laceration, at least); Reporting perineal pain of at least 4 (four) on the visual analogue scale (VAS) at the time of the approach; Present understanding of the Portuguese language and cognitive ability to consent.