Lactation
Conditions
Interventions
This is a randomized controlled clinical trial with three intervention arms, involving a total of 60 participants, with 20 participants in each group. Participants will be mothers of newborns admitted
s assignment to one of the three study groups. Blinding will be applied to the evaluators responsible for data collection and outcome analysis, who will not know the allocation group of the participan
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Mothers over 18 years of age; who have their newborn in the Neonatal Intensive Care Unit (NICU) of the Hospital das Clínicas of the Federal University of Minas Gerais (HC-UFMG) and who are in the mothers' accommodation in the South Wing of HC-UFMG; absence of medical restrictions to exclusive breastfeeding, such as mothers infected with HIV, HTLV1 and HTLV2, or using medications incompatible with breastfeeding; child with galactosemia
Exclusion criteria
Exclusion criteria: Mothers who do not answer all the questions on the questionnaire; mothers who present photosensitivity or any adverse reaction to exposure to sunlight; use of a pacemaker or other electronic implant; undiagnosed lesion in or near the area to be irradiated; history of cancer, surgical wound, or hematoma at the time of inclusion in the study; report of autoimmune diseases that cause skin lesions and/or allergy to adhesive tape; use of bandages or other technical factors that prevent the skin from being exposed to an environment with a balanced temperature; use of lotions, deodorants, preparations, moisturizers, topical analgesics, among others, on the day of the examination; having undergone acupuncture, massages, or electrical stimulation; having been exposed to prolonged sunlight up to 24 hours before the measurements; use of steroids, sympathetic blockers, vasoactive medications, opioids, and transdermal patches in the 24 hours prior to the test; exposure of the skin to hot water; participants who have not fasted for more than 3 hours before the examination; Those who ingested stimulants, nasal decongestants, analgesics, anti-inflammatories, corticosteroids, or any substance that alters sympathetic neurovegetative function in the 24 hours preceding the exam; those who engaged in physical activity on the day of the exam; and those who presented with fever, allergic rhinitis, flu-like symptoms, and/or a cold on the day of the tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An increase in the amount of breast milk produced by participants in the photobiomodulation group is expected, verified by measuring the volume of milk collected in each session using a standardized graduated container, throughout the determined follow-up period. The outcome will be confirmed by observing a significant increase in the average volume of milk produced, comparing the measurements between the experimental and control groups.;A change in breast skin temperature is expected after the application of photobiomodulation, verified by infrared thermography using a calibrated thermographic camera and a standardized image acquisition protocol. The outcome will be confirmed by observing a significant variation in the average temperature of the analyzed regions, comparing pre- and post-intervention measurements between the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactCarine Bicalho
Universidade Federal de Minas Gerais
Outcome results
None listed