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Effect of Laser therapy on pain in lactating postpartum women with nipple Fissures

Effectiveness of a protocol using Photobiomodulation therapy on pain in lactating postpartum women with nipple Fissures: a randomized, controlled, double-blind clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4msv7mh
Enrollment
Unknown
Registered
2025-07-31
Start date
2025-09-01
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

Cracked nipple associated with childbirth

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Fifty women are expected in the size, with 25 in the photobiomodulation therapy group (P_TFB) and 25 in the placebo group (P_P).
the laser mode that will be used is continuous with a dosage of 133.33 J/cm², energy of 4J, and 40 seconds of application for each point determined by the device itself. A trained and qualified physic
for outpatients, the woman will be seated with her feet flat on the floor. The G_P will receive the same procedures as the G_TFB, however, the laser dose will not be programmed. TFB or placebo will be
E02.760.169.063.500

Sponsors

Universidade Federal de Alfenas UNIFAL-MG
Lead Sponsor
Universidade Federal de Alfenas UNIFAL-MG
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Postpartum women over 18 years of age; with nipple fissure secondary to breastfeeding; with pain graded at least two by the NDT; with the ability to understand and answer questions

Exclusion criteria

Exclusion criteria: Women who refused to undergo the intervention; those using other substances on the nipple, such as ointments; presence of a systemic or local infectious process; presence of underlying diseases that make therapy difficult or impossible, such as diabetes mellitus; cancer; neurological diseases; cognitive alterations; pregnancy and photosensitivity

Design outcomes

Primary

MeasureTime frame
It is expected to find a decrease in pain intensity assessed using the Numerical Pain Scale (NPS) in women with nipple fissures due to breastfeeding after 24 hours of photobiomodulation therapy intervention

Secondary

MeasureTime frame
A decrease in the score of the Nipple Trauma Scale is expected, indicating an improvement in the healing of breastfeeding-related nipple fissures, 24 hours after the photobiomodulation therapy intervention

Countries

Brazil

Contacts

Public ContactSimone Pereira

Universidade Federal de Alfenas UNIFAL-MG

comite.etica@unifal-mg.edu.br+55(35)3701-9153

Outcome results

None listed

Source: REBEC (via WHO ICTRP)