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NOT YET RECRUITING
NCT07806526
PHASE2

The Use of Photobiomodulation for Pain and Healing in Cesarean Section

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

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.

Official title: The Use of Photobiomodulation for Pain and Healing in Cesarean Section: A Randomized, Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2027-06

Last Updated

2026-09-08

Healthy Volunteers

Yes

Interventions

RADIATION

Photobiomodulation (PBM)

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.

RADIATION

Placebo PBM

PBM device switched off

OTHER

Standard Hospital Treatment

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.