Mastitis
Conditions
Interventions
This is a randomized controlled clinical trial with two arms and single masking. The study will include a total of 44 participants, allocated into two groups, with 22 participants in the intervention
Sponsors
Centro de Ciências da Saúde da Universidade Estadual de Maringá
Centro de Ciências da Saúde da Universidade Estadual de Maringá
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women of any age, if a minor accompanied by a guardian, who have given birth within the Unified Health System (SUS); who are breastfeeding for up to six months; who have a diagnosis of classic mastitis, characterized by the presence of at least three signs or symptoms compatible with the diagnosis; or who are using antibiotics for a maximum of 48 hours
Exclusion criteria
Exclusion criteria: Lactating women with mastitis of other etiologies; cases associated with the presence of a breast abscess or area of ??fluctuation; clinical situations that contraindicate the use of photobiomodulation (such as neoplasms, use of photosensitive drugs, pregnancy, undiagnosed lesions, tattoos or micropigmentation in the affected area); those who have given birth in private services; those who have been breastfeeding for more than six months and have been using antibiotics for more than 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to evaluate the reduction of pain in breastfeeding mothers with lactational mastitis undergoing photobiomodulation as an adjunct to conventional treatment, verified through the application of the visual analog pain scale. We will observe the indices from the comparison of pre- and post-intervention findings that indicate an improvement in pain intensity;The study aims to evaluate the reduction of breast inflammation in lactating women with lactational mastitis undergoing photobiomodulation, verified through the application of the six-point breast engorgement scale, and clinical observation with verification of the reduction in measurements in centimeters of the inflamed area, based on a comparison of pre- and post-intervention findings that indicate an improvement in the reduction of inflammatory manifestations | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of breastfeeding is expected to be assessed using the LATCH scale, an evaluation tool with defined criteria to measure breastfeeding efficiency, obtaining pre- and post-intervention data to compare the results;The presence of adverse effects is expected to be verified through clinical evaluation and participant reports during the intervention period;The aim is to evaluate the time and evolution of treatment, using clinical assessment and observation during the follow-up period, comparing the outcomes between the groups;The maintenance of breastfeeding is expected to be evaluated for a period of sixty days after treatment, through reports from participants via a telephone interview;Maternal satisfaction is expected to be assessed through participant reports at the end of treatment | — |
Countries
Brazil
Contacts
Public ContactMeliana Paula
Centro de Ciências da Saúde da Universidade Estadual de Maringá
Outcome results
None listed