Photobiomodulation for Episiotomies and Perineal Lacerations After Vaginal Delivery.

NCT06893315 | Completed DMC

• 1 other identifier: LUIRRUARO
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Episiotomies (EP) and perineal lacerations (PL) following vaginal delivery can lead to complications such as pain, edema, and infection. Currently, anti-inflammatory drugs, analgesics, baths, and ice packs are recommended for treatment. Photobiomodulation therapy (PBM) has emerged as a promising technology for pain management and scar healing in EP and PL. This is a cohort observational study conducted at the Maternal and Child University Hospital of the Universidade Estadual de Ponta Grossa, Paraná, Brazil. PBM adjuvant therapy is routinely applied at the bedside daily throughout the postpartum hospitalization. PBM is routinely offered to all postpartum patients during hospitalization. Patients may choose to accept or decline the use of analgesic PBM in addition to the standard therapeutic measures provided by the hospital (anti-inflammatory drugs, analgesics, baths, and ice packs). All patients who underwent EP or suffered grade 2 and 3 PL over six months are evaluated. We will analyze the data from patients who accepted the use of PBM and those who declined the use of PBM regarding the presence of pain, local healing of perineal lacerations, and episiotomies. The primary outcome is the daily pain assessment using the Numerical Pain Scale (NPS) before and after PBM (hospital standard). The secondary outcome is the evaluation of perineal healing using the REEDA scale. Initially, data distribution will be tested using the Kolmogorov-Smirnov test. Comparisons of NPS and REEDA scores between groups that received laser therapy and those that did not received will be performed using repeated-measures ANOVA, considering study covariates. Epidemiological and clinical data (age, sex, marital conditions, type and characteristics of labour (spontaneous or induced), newborn weight, presence of clinical complications during hospitalization ) collected directly in the patients' medical records to characterize the sample. All analyses will be conducted using SPSS 24.0 software, with a significance level of 95%.

Conditions

Perineal Lacerations; Delivery, Obstetric; Episiotomy Wound; Photobiomodulation Therapy; Pain

Keywords

Photobiomodulation; Low-level Laser Therapy; Wound healing; Episiotomy; Pain; Perineal Lacerations

Outcome Measures

Primary Outcomes (1)

• Cutaneous pain

  Perception of local cutaneous pain in the perineum, assessed daily by physiotherapists before and after each PBM session by Numeric Pain Rating Scale (NPRS)

  before and after each PBM session during the 3 days of hospitalization

Secondary Outcomes (1)

• Assessment of perineal lesion healing

  Daily during hospitalization (3 days)

Study Arms (1)

Inpatient normal vaginal delivery postpartum patients

Inpatient postpartum patients during the puerperium who experienced grade 2 or 3 perineal laceration or underwent episiotomy during normal vaginal delivery who were treated during hospitalization with the standard hospital protocol for pain and local wound healing, and who were offered the use of PBM as an additional therapy by standard hospital protocol.

Radiation: Photobiomodulation Therapy; Other: Hospital Standard Protocol of treatment for pain and healing

Interventions

Photobiomodulation Therapy RADIATION

Photobiomodulation (PBM) is a non-invasive therapy that uses low-level light, typically from lasers or Light Emission Diodes (LEDs), to stimulate cellular function and promote healing. It works by delivering specific wavelengths of light to target tissues, which enhances mitochondrial activity and increases adenosine triphosphate (ATP) production. PBM is commonly used for pain relief, reducing inflammation, and accelerating tissue repair in conditions like muscle injuries, arthritis, and skin disorders.

Inpatient normal vaginal delivery postpartum patients

Hospital Standard Protocol of treatment for pain and healing OTHER

Medical team evaluations are conducted daily throughout the hospitalization period, and anti-inflammatory medications (ketoprofen ), analgesics (dipyrone), and, in cases where vulvar edema is observed, ice packs are prescribed. In addition to the standard treatment described, the health care team routinely offers patients the use of laser therapy (photobiomodulation) once a day during hospitalization. Patients who agree to the laser therapy receive both treatments.Patients who do not accept receiving PBM receive exactly only the same standard routine care described. These protocols are standardized at the hospital, and this observational study did not interfere with any care practices.

Inpatient normal vaginal delivery postpartum patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only women in labor
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing episiotomy or patients who presented grade 2 or 3 perineal laceration during vaginal childbirth. The diagnosis of the degree of laceration is clinical and the obstetrician responsible for the patient's care treatment did so by exploring the injury and visualizing the injured structures within the hospital's care routine. Only those patients in whom the diagnosis of grade 2 or 3 perineal laceration made by the responsible care team and documented in the medical record were invited to participate in the study.

You may qualify if:

• Adult women over 18 years of age;
• Parturients with a gestational age equal to or greater than 37 weeks;
• Patients who had a vaginal birth;
• Patients undergoing episiotomy or patients who presented grade 2 or 3 perineal laceration during childbirth.

You may not qualify if:

• Multiple pregnancy (twins);
• Presence of fetal malformation or death identified during prenatal care or at the time of hospitalization for delivery;
• Patients with serious complications such as severe puerperal hemorrhage or HELLP Syndrome during childbirth.
• Patients with grade 1 or 4 perineal lacerations.
• Presence of systemic diseases that alter the repair process.
• Withdrawal of the nformed Consent Form" (ICF) at the request of the patient or those responsible;

Sponsors & Collaborators

• University of Nove de Julho: lead
• Universidade Estadual de Ponta Grossa: collaborator

Study Sites (1)

Hospital Universitário Materno-Infantil da Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, 05020000, 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

Study Officials

• Rebeca B Cecatto, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor M.D. Ph.D. Rebeca Boltes Cecatto

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after analysis of results
• Access Criteria: The raw data without identification of these patients will be saved in an open access repository such as Mendeley Data or similar. The results of this study, whether favorable or not, will be published in impact journals.

Locations

BR (1)