A Phase 2 interventional study of Photobiomodulation (PBM) and Placebo PBM in Post Partum, Cesarean Birth and Pain Management, sponsored by University of Nove de Julho. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Nove de Julho · Phase 2, Interventional, and Treatment
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.
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. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.
University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 - 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
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.
PBM device switched off
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.
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.
Time frame: 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: 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.
Time frame: 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean
Amount of analgesic medications used (dosage, mg, and regimen)
For the inpatient phase, this information will be extracted directly from the participants' medical records, as these data are routinely collected by the clinical care team. After hospital discharge, this information will be collected via telephone at 5, 10, and 40 days post-procedure, through an anamnesis/video consultation with the participants.
Time frame: Immediately after cesarean, 24 and 48 hours after cesarean, and 5, 10, and 40 days post-procedure,
Occurrence of postoperative complications
For the inpatient phase, this information will be collected on-site by the research team. After hospital discharge, this information will be collected via telephone through an anamnesis/video consultation with the participants. During the video consultation, a visual assessment of the surgical incision's progression will be performed to investigate the following complications: Inflammatory signs (flogistic signs); Presence of pus; Presence of moisture/exudate; Presence of granulation tissue; Incisional bulging/raised areas; Local edema; Local hyperemia; Suture dehiscence; Local hematoma; Incisional bleeding; Local discharge/exudate; Scar fistulization; Scar retraction/contracture; Suture loss (missing stitches); Orange-peel edema (peau d'orange).
Time frame: Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean
Functionality
This information will be collected via telephone interview through an anamnesis with the participants. The following questions will be asked: Are you able to hold your baby in your arms while standing? Are you able to take a shower standing up by yourself? Are you able to go up and down stairs or steps? Have you experienced any discomfort during bowel movements?
Time frame: 5, 10, and 40 days post-procedure
Adverse effects
Any adverse effect related to PBM founded after study will be report
Time frame: immediately postoperatively, as well as 24 and 48 hours after surgery.
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.
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