Instituto Materno Infantil Prof. Fernando Figueira
Phase
Not applicable
Started
2026-04-01
Last updated
2026-03-18
Condition(s) studied
PainPerineal Healing
Investigational drug(s) / intervention(s)
low-level laser therapySham treatment
low-level laser therapy: Low-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: Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Postpartum women/multiparous women aged 18 years or older;
Postpartum women/multiparous women in the immediate postpartum period after vaginal birth;
Postpartum women/multiparous women with spontaneous perineal laceration (Grade II, III, or IV);
Postpartum women/multiparous women with an average pain score of at least 3 on the Visual Analog Scale (VAS);
Labor duration up to 18 hours.
Exclusion Criteria:
Postpartum women/multiparous women classified as high-risk during pregnancy due to a diagnosis of gestational diabetes mellitus; type 1 or type 2 diabetes mellitus; chronic or pregnancy-specific hypertension; smoking; alcohol use; use of psychoactive substances, among others;
Postpartum women/multiparous women who present postpartum complications (such as hemorrhage, difficulty in verbal communication, or sepsis);
Postpartum women/multiparous women who develop clinical or hemodynamic complications after childbirth;
Postpartum women/multiparous women whose newborns died or were admitted to a Neonatal Intensive Care Unit (NICU);
Women with communication difficulties (impaired understanding or mental disorders).
Primary outcome measure(s)
Perineal pain intensity (VAS) (immediate) — 30 minutes 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 — 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 — 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 — 30 minutes 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.
Assessment of Wound Healing (REEDA) - 24 Hours — 24 Hours Perineal wound healing will be assessed 24 hours postpartum 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 24 hours after delivery.
Trial sites (1)
Facility
City
Region
Status
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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