The Use of Photobiomodulation for Pain and Healing in Cesarean Section

NCT07806526 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PBMMANDAQUIFLAVIA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points.

Conditions

Post Partum; Cesarean Birth; Pain Management; Wound Care

Keywords

Photobioimodulation; Post Partum; Cesarean Birth; Pain management; Wound Care

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.

  Baseline" or "Day 1" , immediately after cesarean, immediately before and PBM session on 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean

• Intensity Pain

  The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a McGill Pain Questionnaire (Brazilian Portuguese validated version).

  Time Frame: Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean

• Cesarean Wound Healing

  Edema and local wound healing will be assessed using the REEDA scale (Hill, 1990), which evaluates the inflammatory process and tissue repair following perineal trauma. Five healing parameters are assessed: redness, edema, ecchymosis, discharge, and approximation of wound edges (coaptation). Each item is scored from 0 to 3 by the evaluating clinician, with a maximum total score of 15 points indicating the poorest wound healing.

  24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean

Secondary Outcomes (4)

• Amount of analgesic medications used (dosage, mg, and regimen)

  Immediately after cesarean, 24 and 48 hours after cesarean, and 5, 10, and 40 days post-procedure,

• Occurrence of postoperative complications

  Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean

• Functionality

  5, 10, and 40 days post-procedure

• Adverse effects

  immediately postoperatively, as well as 24 and 48 hours after surgery.

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Treatment Group - application of Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.

Radiation: Photobiomodulation (PBM); Other: Standard Hospital Treatment

Controlled Group

PLACEBO COMPARATOR

Controlled Group - application of placebo Photobiomodulation (PBM) therapy to the abdominal skin scar from the cesarean section, in addition to the standard hospital management treatment according to the institution's protocol.

Radiation: Placebo PBM; Other: Standard Hospital Treatment

Interventions

Photobiomodulation (PBM) RADIATION

PBM device with an output power of 100 W, equipped with a Red Laser probe (658 nm) delivering 3 Joules per point over 6 points along the incision, and an Infrared probe (830 nm) delivering 4.5 Joules per point, applied to as many points as necessary to cover the entire perimeter around the incision, with a 1-cm distance between each point and from the incision itself.

Treatment Group

Placebo PBM RADIATION

PBM device switched off

Controlled Group

Standard Hospital Treatment OTHER

Standard individualized analgesic and wound-healing treatment for the surgical incision, as routinely provided by the hospital's healthcare team, under the coordination and evaluation of the patients' routine clinical care staff. The women will remain under the clinical routine prescribed by their attending medical team.

Controlled Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Adults
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing cesarean section, regardless of whether indicated during labor or electively by maternal request;
• Under follow-up at the Mandaqui Hospital Complex "Bispa Keila Campos Costa Ferreira" by the local Obstetrics team;
• Admitted to the Hospital for delivery (either by referral or spontaneous demand) with adequate prenatal care (minimum of 7 visits);
• Aged between 18 and 45 years;
• Have undergone adequate prenatal follow-up;
• Have a mobile phone with internet access and a video-calling application.

You may not qualify if:

• Women with multiple gestation;
• Women with uncontrolled systemic diseases;
• Women with active infectious conditions as an indication for pregnancy resolution (e.g., patients with chorioamnionitis);
• Women with a prior diagnosis of coagulation disorders;
• Women with grade 3 obesity (BMI ≥ 40 kg/m²);
• Women with photosensitivity;
• Women with more than 2 previous cesarean sections (repeated/recurrent cesareans).
• Women who, at the time of delivery, did not receive intraoperative prophylactic antibiotic therapy, who present secondary skin lesions from recent local shaving/trichotomy, or who were not submitted to preoperative surgical site degerming/preparation (all of which are measures that impact the reduction of surgical site infection risk);
• Parturients who presented clinical complications during the immediate pre-hospital, intra-hospital, or intrapartum period.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Agnosia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Rebeca B Cecatto, Ph.D.

CONTACT

11970842496; rebeca.boltes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor M.D. Ph.D. Rebeca Boltes Cecatto

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 8, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09