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Light Therapy for Treatment of Lesions of the Nipple

Photobiomodulation as a New Approach for the Treatmment of Nipple Traumas: A Pilot Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7zmz55
Enrollment
Unknown
Registered
2011-07-03
Start date
2010-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Injuries to the nipple (fissures and cracks) resulting breastfeeding.

Interventions

Participants will be randomly assigned to one of two treatment groups: control or experimental. The control group will receive guidance on breastfeeding and the experimental group will receive, in add
Other
E02.774

Sponsors

PUC Minas
Lead Sponsor
PUC Minas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: To participate in the study, women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years.

Exclusion criteria

Exclusion criteria: Exclusion criteria was considered: previous history of cancer, use of other therapeutic modalities that might interfere with the healing of the lesions, presence of infected wounds, history of photosensitivity to light, cognitive deficits that undermine the understanding and implementation of guidelines of care for breast.

Design outcomes

Primary

MeasureTime frame
Size and classification of injuries: wounds nipple will be measured weekly in the initial assessment and for six consecutive weeks, using a digital caliper and classified at the beginning and end of treatment according to Pereira et al (1998). The measurements and classification of cracks will be conducted by a researcher previously trained to perform procedures.;Pain: pain intensity will be evaluated using the Visual Numeric Scale (VNS). The EVN will be applied at baseline and at the beginning of each week of treatment, for six consecutive weeks.

Secondary

MeasureTime frame
Quality of life: the impact of the presence of nipple fissures and cracks in the quality of life of the mothers will be assessed by the SF-36 (short version), applied at baseline, in the third and sixth weeks of the study.

Countries

Brazil

Contacts

Public ContactAngélica Araújo

PUC Minas

angelica@bios.srv.br+55(31)3319-4425

Outcome results

None listed

Source: REBEC (via WHO ICTRP)