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

Effectiveness of Low-Level Laser Therapy Compared to Sham Treatment on Pain Intensity and Perineal Wound Healing Quality in the Immediate Postpartum Period: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Perineal Healing
• Intervention / Treatment: Device: low-level laser therapy; Device: Sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leila Katz, PhD; Phone Number: +5581988585977; Email: leilakatz@hotmail.com

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Instituto de Medicina Integral Professor Fernando Figueira - IMIP
      • Contact: Alexandre M Delgado, PhD; Phone Number: +5581996184843; Email: alexmagno_d@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; low-level laser therapy	Device: 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.; Other Names: photobiomodulation
Sham Comparator: Control; sham treatment	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours
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.	48 Hours
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.	48 Hours
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.	48 Hours
Adverse Effects of Laser Therapy	Adverse effects associated with laser therapy will be monitored and recorded throughout the study period. Participants will be assessed for the presence of potential adverse events, including itching (pruritus), tingling sensation (paresthesia), and blister formation at the application site.	48 Hours
Complications of Perineal Laceration	Complications related to perineal laceration will be monitored and recorded during the postpartum period. These complications include suture dehiscence, surgical site infection, need for surgical reintervention, and postpartum wound bleeding.	48 Hours

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: LaserPerineal; 92318425.0.0000.5201 (Other Identifier: IMIP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No