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Use of Low-Intensity Laser with Methylene Blue to treat Nipple Cracks during Breastfeeding

Effect of Low-Intensity Laser at the red wavelength associated with Methylene Blue for the treatment of Breast Fissures: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6jt2f8b
Enrollment
303
Registered
2026-04-07
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding Breast Diseases

Interventions

It is a randomized controlled, double-blind trial with 3 groups, each consisting of 101 participants aged between 18 and 40 years, who are exclusively breastfeeding their infants and present with nipp

Sponsors

Universidade Federal do Delta do Parnaíba
Lead Sponsor
Universidade Federal do Delta do Parnaíba
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Postpartum women; aged between 18 and 40 years; who present with unilateral or bilateral nipple fissures, confirmed by a healthcare professional, for at least 1 week; with reported nipple pain greater than or equal to 5 on the Visual Analogue Scale (VAS); who are exclusively breastfeeding; those who agree to participate in the study must sign the Informed Consent Form, present in Appendix A

Exclusion criteria

Exclusion criteria: Postpartum women with active breast infection; participants undergoing any other topical treatment for the fissure, such as healing ointments, antibiotics, antifungals, or corticosteroid therapy; patients with a history of autoimmune skin diseases, atopic dermatitis in the breast area, or breast cancer; HIV/AIDS positive; participants with contraindications to photonic therapy; people with psychiatric disorders; and those who request to be withdrawn from the research.

Design outcomes

Primary

MeasureTime frame
An improvement in the healing process of nipple fissures in breastfeeding women is expected, verified through the application of the Nipple Trauma Scale and the measurement of the circumference of the nipple fissures, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements.

Secondary

MeasureTime frame
It is expected that there will be an improvement in pain levels and quality of life in breastfeeding mothers, verified through the Visual Analogue Scale and the WHOQOL-BREF questionnaire, based on the observation of reduced pain scores and increased quality of life scores among the assessments in volunteers with adequate adherence to treatment

Countries

BR

Contacts

Public ContactGuilherme Gouveia

Universidade Federal do Delta do Parnaíba

gpfatufpi@gmail.com+55(86)988016456

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026