Fissure and fistula of nipple
Conditions
Interventions
Two-arm, double-blind, randomized controlled clinical trial. Two interventions will be performed with an interval of 24 hours. All volunteers will receive guidance on breastfeeding, breast care and ne
E02.594.540
Sponsors
Universidade de Pernambuco
Universidade de Pernambuco
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women; age from 18 years until 41 years; primiparous or multiparous; postpartum women up to 15 days postpartum; with some degree of nipple injury resulting from breastfeeding; babies born weighing at least 2500g; single pregnancy; in exclusive breastfeeding; no history of interventions with laser therapy in the previous 15 days; able to speak and understand the Portuguese language; who show interest in the project; be able to attend the Women's Health Research Laboratory (LAPESM); who can receive calls and messages via Whatsapp within 48 hours of the intervention; who sign the Free and Informed Consent Form (TCLE);
Exclusion criteria
Exclusion criteria: Women with inverted or pseudo-inverted nipples; who have mastitis during the intervention period; to start using antibiotic anti-inflammatory analgesics or any topical substance on the nipple (except breast milk); with photosensitivity or any adverse reaction to exposure to sunlight;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will evaluate the acute effect of photobiomodulation in the red and infrared range, on changes in the perception of pain intensity, in relation to nipple injury, through the numeric pain scale (0-10 points) and the Short Form questionnaire McGill (for descriptive pain data), all assessments will occur before and after each intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will evaluate the acute effect of photobiomodulation in the red (660nm) and infrared (880nm) range, on the healing of the nipple lesion and on the signs of inflammation, using measurements in millimeters with a measuring tape for each lesion and a checklist of the five signs of inflammation, all assessments will occur before and after each intervention. The patients' global perception of change with photobiomodulation after 24 hours of the second intervention, the degree of satisfaction of the participants, immediately after the second intervention, with regard to the physiotherapeutic intervention, as well as any side effects arising from the applied intervention will also be evaluated. | — |
Countries
Brazil
Contacts
Public ContactAmanda Valença
Universidade de Pernambuco
Outcome results
None listed