Menu
Not yet recruiting NCT07480083

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

No phase Interventional Pain Perineal Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low-level laser therapy, Sham treatment.
Who it may be relevant to
Registry conditions: Pain, Perineal Healing. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Perineal pain intensity (VAS) (immediate) [Time frame: 30 minutes]
  • Perineal Pain Intensity (VAS) - 24 hours [Time frame: 24 hours]
  • Perineal Pain Intensity (VAS) - 48 Hours [Time frame: 48 Hours]
  • Assessment of wound healing (REEDA) - immediate [Time frame: 30 minutes]
  • Assessment of Wound Healing (REEDA) - 24 Hours [Time frame: 24 Hours]
Secondary outcome measures (6)
  • Need for Pharmacological Analgesia [Time frame: 48 hours]
  • Global Change Perception Scale (GCPS) Assessment [Time frame: 48 Hours]
  • Maternal Satisfaction Level [Time frame: 48 Hours]
  • Adherence to the Intervention [Time frame: 48 Hours]
  • Adverse Effects of Laser Therapy [Time frame: 48 Hours]
  • Complications of Perineal Laceration [Time frame: 48 Hours]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP — Recife

Identifiers

NCT: NCT07480083 · LaserPerineal · 92318425.0.0000.5201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗