Mastitis
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. The sample will consist of 120 participants.
In the nipple trauma arm: lactating women between 6 and 36 hours after delivery who
30 in the control group). Randomization will be performed using computer software, followed by allocation with blinding. The experimental group will receive an application of 2 Joules of visible energ
30 in the control group ). Randomization will be performed using computer software, followed by allocation with blinding. The experimental group will receive an application on the lesion of 4 Joules o
E02.594.540
Sponsors
Centro de Atenção Integral à Saúde da Mulher
Centro de Atenção Integral à Saúde da Mulher
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for the Nipple Trauma group: Older than 18 years; Who are breastfeeding and have nipple trauma; Present understanding of the Portuguese language and cognitive ability to consent; Reporting nipple pain of at least 4 (four) on the visual analogue scale (VAS) at the time of approach. Inclusion criteria for the Perineal Trauma group: Older than 18 years; Who have perineal injuries resulting from childbirth (episiotomy or 2nd-degree laceration, at least); Reporting perineal pain of at least 4 (four) on the visual analogue scale (VAS) at the time of the approach; Present understanding of the Portuguese language and cognitive ability to consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the Nipple Trauma group: Mastitis or neoplasm; Photosensitivity to exposure to sunlight; Breast malformation, breast implant, or breast reduction surgery. Exclusion criteria for the Perineal Trauma group: Active gynecological infections; Unresolved puerperal hemorrhage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the perineal trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Short Form McGill Pain Questionnaire (observing a minimum reduction of 5 points in the Pain Index). Pain Rating; 1 point on the Present Pain Intensity Scale; and 1.37 cm on the Visual Analogue Scale) and the Numerical Pain Assessment Scale (observing a minimum reduction of 2 points). In the nipple trauma arm: With the application of photobiomodulation, a significant reduction in mean pain is expected in the experimental group compared to the sham group, using the Visual Analogue Scale (observing a minimum reduction of 1.37 cm) and the Numerical Scale of Pain Assessment (observing a minimum reduction of 2 points). | — |
Secondary
| Measure | Time frame |
|---|---|
| In both arms, healing and satisfaction will be evaluated through a telephone interview, using a Likert scale, presenting the percentile of improvement in healing and satisfaction. | — |
Countries
Brazil
Contacts
Public ContactFernanda Surita
Universidade Estadual de Campinas
Outcome results
None listed