Effect of LED Therapy for Treatment Nipple Fissure

Not Applicable

• Conditions: Nipple Disorder
• Interventions: Device: Led Therapy

• Registration Number: NCT03496753
• Lead Sponsor: University of Nove de Julho

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

Study Timeline

• Study First Submitted: 2018-03-28
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12
• Study Start: 2018-08-20
• Primary Completion: 2018-09-20
• Study Completion: 2019-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Led Therapy	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.

Primary Outcome Measures

Name	Time	Method
Nipple fissure	1 week	Nipple fissure will be evaluate with digital calipers - Black Bull Scale

Trial Locations

Locations (1)

Mandaqui Hospital; 🇧🇷 São Paulo, Sao Paulo, Brazil