Photobiomodulation for Episiotomies and Perineal Lacerations After Vaginal Delivery.

NCT ID: NCT06893315

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-07-31

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%.

Detailed Description

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 therapy is routinely applied at the bedside daily throughout the postpartum hospitalization. It is standard practice at the hospital to offer adjuvant PBM in addition to the standard treatment (anti-inflammatory drugs, analgesics, baths, and ice packs). However, the use of PBM is optional for patients during hospitalization. The PBM parameters are: laser with a wavelength of 808 nm and a power of 100 mW applied at 5 points around the PL or EP for a total application time of 5 minutes. 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 period are evaluated. Since PBM is routinely offered to patients, after approval by the ethics committee, the principal investigator, monitored all included participants at the hospital and collected routine hospital data from medical records regarding the outcomes. We will analyze the medical record data related to the outcomes for statistical analysis. 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 outcomes will be analyzed by comparing the following participant subgroups: 1. participants who declined to receive PBM in addition to the hospital's standard treatment, and 2. participants who accepted to receive PBM in addition to the hospital's standard treatment. 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 will be performed using repeated-measures ANOVA, considering study covariates. All analyses will be conducted using SPSS 24.0 software, with a significance level of 95%. 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 and evaluate factors influencing the response to PBM regarding the assessed outcomes

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Photobiomodulation Therapy

Intervention Type: 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.

Hospital Standard Protocol of treatment for pain and healing

Intervention Type: 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.

Interventions

Photobiomodulation Therapy

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.

Intervention Type: RADIATION

Hospital Standard Protocol of treatment for pain and healing

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Rebeca Boltes Cecatto

Professor M.D. Ph.D. Rebeca Boltes Cecatto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebeca B Cecatto, PhD

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

Hospital Universitário Materno-Infantil da Universidade Estadual de Ponta Grossa

Ponta Grossa, Paraná, Brazil

Countries

Brazil

Other Identifiers

LUIRRUARO

Identifier Type: -

Identifier Source: org_study_id