Effect of LED Therapy for Treatment Nipple Fissure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2019-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Laser Therapy in Nipples Injured During Breastfeeding

NCT01723995

Nipple Trauma

COMPLETED NA

Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

NCT01462019

Injuries to the Nipple (Fissures and Cracks) Resulting Breastfeeding

COMPLETED PHASE1/PHASE2

Healing Nipple Wounds: Comparison Between 2 Treatment Modalities

NCT03389516

Nipple Wounds

UNKNOWN PHASE4

Low-Level Laser Therapy (LLLT) Treatment for Breast-Feeding Women With Painful Nipple Lesions

NCT04259619

Nipple Lesions

RECRUITING NA

Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

NCT01420419

Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nipple Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Statistic analysis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Led Therapy

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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