This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period. The study seeks to determine whether low-level laser therapy can reduce perineal pain and improve healing outcomes in women with perineal trauma after vaginal birth.
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Parallel
low-level laser therapy
DeviceLow-level laser therapy will be applied to the perineal region of postpartum women with perineal trauma after vaginal birth. The intervention will be performed using a low-level laser device applied directly to the perineal wound area in the immediate postpartum period. The laser will be administered according to predefined parameters (wavelength, energy density, and application time) to promote analgesia and enhance tissue repair.
Sham treatment
DeviceParticipants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.
Perineal pain intensity (VAS) (immediate)
Perineal pain intensity will be assessed using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest. The assessment will be performed in the immediate postpartum period following the intervention.
Perineal Pain Intensity (VAS) - 24 hours
Perineal pain intensity will be assessed 24 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest at 24 hours after delivery.
Perineal Pain Intensity (VAS) - 48 Hours
Perineal pain intensity will be assessed 48 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest 48 hours after delivery.
Assessment of wound healing (REEDA) - immediate
Perineal wound healing will be assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Approximation), a validated instrument used to evaluate the healing process of perineal trauma. Each item is scored from 0 to 3, with total scores ranging from 0 to 15, where lower scores indicate better healing. The assessment will be performed in the immediate postpartum period following the intervention.
Need for Pharmacological Analgesia
The need for pharmacological analgesia will be recorded during the postpartum period. This outcome will assess whether participants required analgesic medication for perineal pain management after the intervention.
Global Change Perception Scale (GCPS) Assessment
Participants' perceived overall change in their clinical condition will be evaluated using the Global Change Perception Scale (GCPS). This scale measures the participant's subjective perception of improvement or worsening of symptoms after the intervention. Participants will be asked to rate their perceived change compared with their initial condition.
Maternal Satisfaction Level
Maternal satisfaction with the intervention will be assessed using a Visual Analog Scale (VAS), ranging from 0 to 10, where 0 represents "not satisfied at all" and 10 represents "completely satisfied." Participants will be asked to rate their level of satisfaction with the care received during the immediate postpartum period.
Adherence to the Intervention
Adherence to the intervention will be evaluated by recording participants' compliance with the assigned treatment protocol. This outcome will assess whether participants received and completed the intervention as planned during the study period.
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