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Effect of LED Therapy for Treatment Nipple Fissure

Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496753
Acronym
ELTTNF
Enrollment
100
Registered
2018-04-12
Start date
2018-08-20
Completion date
2019-08-20
Last updated
2018-04-12

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

Conditions

Nipple Disorder

Keywords

nipple fissure

Brief summary

Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain.

Detailed description

Nipple fissures are the second major cause of the discontinuation of breastfeeding, following a sensation of insufficient milk, which leads to bottle feeding. Poor positioning of the child in relation to the breast, an inadequate frequency or duration of breastfeeding and improper suckling are the main causes of nipple fissure. Discontinuing breastfeeding deprives the infant of essential nutrients and also deprives the mother of certain health benefits. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures. The aim of this study is to evaluate LED therapy in treatment of nipple fissures

Interventions

The following will be the phototherapeutic parameters: total spot area: 1.44 cm²; continuous emission mode; output power: 10 mW; infrared wavelength (880 to 904 nm); fluence: 4 J/cm²; and application time: 10 minutes/session. Sessions will be held three times a week on alternating days for six consecutive weeks, totaling 18 sessions.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Statistic analysis

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Nursing mothers aged 18 years or older 2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales 3. Having given birth to a healthy, full-term child 4. Performing exclusive breastfeeding 5. Newborn with no oral, palatal or maxillofacial abnormalities 6. Newborn weighing between 2500 and 4000 grams

Exclusion criteria

1. History of psychological disorder 2. Presence of mastitis 3. Bacterial or fungal infection in breasts 4. Use of breast pump or plastic nipple

Design outcomes

Primary

MeasureTime frameDescription
Nipple fissure1 weekNipple fissure will be evaluate with digital calipers - Black Bull Scale

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026