Early photobiomodulation in nipple pain and injury during breastfeeding: pilot double-blind randomized clinical trial.

OBJECTIVE: To verify the feasibility of a randomized clinical trial to test the effects of early photobiomodulation on nipple pain and injury resulting from breastfeeding. METHOD: External pilot study for a randomized clinical trial, conducted between June and December 2023. Postpartum women with a gestational age ≥ 37 weeks, admitted to the shared rooms of two maternity hospitals in Paraná, Brazil, were included. Participants were randomly allocated by lottery to Groups: A (local photobiomodulation); B (Intravenous Laser Irradiation of Blood - systemic); C (local and systemic photobiomodulation) or D (control group), received two sessions of the intervention, were followed up in the first month postpartum, and data were collected at five time points. RESULTS: 58 postpartum women started the study, with a loss to follow-up of 20%. The pilot study reinforced the feasibility of the large-scale clinical trial and allowed for the adaptation of the protocol, the adjustment of the sample estimate, and the standardization of guidelines. CONCLUSION: Conducting a large-scale clinical trial is feasible and viable from a methodological and operational standpoint, with the potential to generate robust evidence on the role of photobiomodulation in the early management of nipple pain and injury, contributing to the reduction of maternal distress resulting from pain and injury, and preventing early weaning.