Perineal LacerationsNCT06893315
Photobiomodulation for Episiotomies and Perineal Lacerations After Vaginal Delivery.
An observational study of Perineal Lacerations and Delivery, Obstetric, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Lacerations, Delivery, Obstetric, Episiotomy Wound
- What is being tested?
- Photobiomodulation Therapy and Hospital Standard Protocol of treatment for pain and healing
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2024to 1 Jun 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Materno-Infantil da Universidade Estadual de Ponta Grossa
Ponta Grossa, Paraná, 05020000
About this study
Official title: Photobiomodulation Therapy for Pain and Healing in Episiotomies and Grade 2 and 3 Perineal Lacerations After Vaginal Delivery: An Observational Study.
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%.
Read the 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
- Being tested
- Photobiomodulation Therapy, Hospital Standard Protocol of treatment for pain and healing
- Keywords
- Photobiomodulation, Low-level Laser Therapy, Wound healing, Episiotomy, Pain, Perineal Lacerations
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyRadiation
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 healingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Photobiomodulation Therapy; Other: Hospital Standard Protocol of treatment for pain and healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: before and after each PBM session during the 3 days of hospitalization
Secondary outcomes (1)
Assessment of perineal lesion healing
Assessment of perineal lesion healing using the REEDA scale daily
Measured: Daily during hospitalization (3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal LacerationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Ponta Grossa
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
- Investigators
- Rebeca B Cecatto, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893315
- Sponsor's protocol ID
- LUIRRUARO
- Status last verified
- Apr 2026
- First submitted
- 18 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Therapy for Pain and Healing in Episiotomies and Grade 2 and 3 Perineal Lacerations After Vaginal Delivery: An Observational Study.
- ClinicalTrials.gov ID
- NCT06893315
- Acronym / sponsor ID
- LUIRRUARO
- Conditions
- Perineal Lacerations, Delivery, Obstetric, Episiotomy Wound, Photobiomodulation Therapy, Pain
- Keywords
- Photobiomodulation, Low-level Laser Therapy, Wound healing, Episiotomy, Pain, Perineal Lacerations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Universidade Estadual de Ponta Grossa
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatient normal vaginal delivery postpartum patients | – | Radiation: Photobiomodulation Therapy, Other: Hospital Standard Protocol of treatment for pain and healingInpatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation TherapyPhotobiomodulation (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. | Radiation | Inpatient normal vaginal delivery postpartum patients |
| Hospital Standard Protocol of treatment for pain and healingMedical 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. | Other | Inpatient normal vaginal delivery postpartum patients |
Primary outcome
Cutaneous pain
Time frame: before and after each PBM session during the 3 days of hospitalization
Perception of local cutaneous pain in the perineum, assessed daily by physiotherapists before and after each PBM session by Numeric Pain Rating Scale (NPRS)
1 secondary outcome
Assessment of perineal lesion healing
Time frame: Daily during hospitalization (3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Perineal Lacerations
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Vaginal Laceration During Delivery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebeca B Cecatto, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Lacerations and Delivery, Obstetric, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous pain (time frame: before and after each PBM session during the 3 days of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.