Effect of LED Therapy for Treatment Nipple Fissure (ELTTNF)
Effect of LED Therapy for the Treatment Nipple Fissures: a Randomized Controlled Trial
Study Overview
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo
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São Paulo, Sao Paulo, Brazil, 02401400
- Mandaqui Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nursing mothers aged 18 years or older
- Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales
- Having given birth to a healthy, full-term child
- Performing exclusive breastfeeding
- Newborn with no oral, palatal or maxillofacial abnormalities
- Newborn weighing between 2500 and 4000 grams
Exclusion Criteria:
- History of psychological disorder
- Presence of mastitis
- Bacterial or fungal infection in breasts
- Use of breast pump or plastic nipple
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Led Therapy
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.
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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.
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No Intervention: Control
The control group will receive orientation regarding breast care and adequate breastfeeding techniques.
The experimental group will receive the same orientation plus phototherapy sessions using a device developed especially for the treatment of nipple trauma.
Both groups will be followed up for six consecutive weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nipple fissure
Time Frame: 1 week
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Nipple fissure will be evaluate with digital calipers - Black Bull Scale
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1 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LEDNipple01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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