Effect of LED Therapy for Treatment Nipple Fissure

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Nipple Disorder

Intervention / Treatment
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* Device: Led Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Led Therapy<br>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. | Device: Led Therapy<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple fissure | Nipple fissure will be evaluate with digital calipers - Black Bull Scale | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nipple fissure