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Use of photobiomodulation in users of the breastfeeding clinic in the SUS-BH network

Breastfeeding clinic in the SUS-BH network: characterization of users of the service and use of Photobiomodulation in nipple trauma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7mhpvxk
Enrollment
Unknown
Registered
2023-06-15
Start date
2021-08-09
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

Pain Measurement

Interventions

This is a randomized, double-blind clinical trial. Participants will be divided into two groups. 25 participants will be allocated in each of the groups. The intervention group will receive a red lase
continuous emission mode, punctual (at the site of injury), without contact
frequency of 100 Hz
power of 100mw
energy of 1 J, lasting 10 seconds. For analgesia, a DMC laser device will be used, with the following dosimetric parameters: light wavelength of 810 nm
continuous, punctual, contact emission mode
energy of 4 J, in a cross shape, on the areola, lasting 40 seconds at each point. The study is characterized as double-blind because the participants will not know if they were allocated in the interv
E02.594

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Postpartum women over 18 years old; nursing mothers; with a diagnosis of abrasions, breast fissures or ulcerations in at least one of the breasts; absence of cognitive deficit; absence of malignant alterations for puerperal women; absence of ankyloglossia with indication of frenotomy for babies

Exclusion criteria

Exclusion criteria: Postpartum women who have photosensitivity or any adverse reactions to exposure to sunlight; who is pregnant; who is using other forms of treatment for nipple trauma (ointments, sunbathing, own milk, among others); undiagnosed lesions on the area to be irradiated or close to it; infection at the application site; use of a pacemaker or other electronic implant; who present a diagnosis of mastitis or breast candidiasis, during the development of the study, according to a medical evaluation

Design outcomes

Primary

MeasureTime frame
It is expected to verify a reduction in the area of ??the lesion, by measuring the area of ??the lesion before and after the intervention

Secondary

MeasureTime frame
It is expected to verify pain reduction, through the use of the visual analogue pain scale, pre and post intervention

Countries

Brazil

Contacts

Public ContactCamila Martins

Universidade Federal de Minas Gerais

camiladantas@pbh.gov.br+5531988547090

Outcome results

None listed

Source: REBEC (via WHO ICTRP)