Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial.

NCT07480083 | Not Yet Recruiting DMC

• 2 other identifiers: LaserPerineal92318425.0.0000.5201
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Perineal Healing

Outcome Measures

Primary Outcomes (5)

• 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.

  30 minutes

• 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.

  24 hours

• 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.

  48 Hours

• 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.

  30 minutes

• Assessment of Wound Healing (REEDA) - 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.

  24 Hours

Secondary Outcomes (6)

• Need for Pharmacological Analgesia

  48 hours

• Global Change Perception Scale (GCPS) Assessment

  48 Hours

• Maternal Satisfaction Level

  48 Hours

• Adherence to the Intervention

  48 Hours

• Adverse Effects of Laser Therapy

  48 Hours

Study Arms (2)

Experimental group

EXPERIMENTAL

low-level laser therapy

Device: low-level laser therapy

Control

SHAM COMPARATOR

sham treatment

Device: Sham treatment

Interventions

low-level laser therapy DEVICE

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.

Also known as: photobiomodulation

Experimental group

Sham treatment DEVICE

Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernambuco, 50070-550, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Leila Katz, PhD

CONTACT

+5581988585977; leilakatz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)