Post PartumPhase 2NCT07806526
The Use of Photobiomodulation for Pain and Healing in Cesarean Section
A Phase 2 study testing Photobiomodulation (PBM) and Standard Hospital Treatment in people with Post Partum and Cesarean Birth, run by University of Nove de Julho.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum, Cesarean Birth, Pain Management
- What is being tested?
- Photobiomodulation (PBM) and Standard Hospital Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2027
- Phase
- Phase 2
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Use of Photobiomodulation for Pain and Healing in Cesarean Section: A Randomized, Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Post Partum, Cesarean Birth, Pain Management, Wound Care
- Being tested
- Photobiomodulation (PBM), Placebo PBM, Standard Hospital Treatment
- Keywords
- Photobioimodulation, Post Partum, Cesarean Birth, Pain management, Wound Care
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo PBMRadiation
PBM device switched off
Standard Hospital TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Placebo PBM; Other: Standard Hospital Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
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.
Measured: 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).
Measured: 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?
Measured: 5, 10, and 40 days post-procedure
Adverse effects
Any adverse effect related to PBM founded after study will be report
Measured: immediately postoperatively, as well as 24 and 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post PartumStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Boltes Cecatto, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806526
- Sponsor's protocol ID
- PBMMANDAQUIFLAVIA
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No