Effect of LED Therapy for Treatment Nipple Fissure

NCT03496753 | Unknown

• 1 other identifier: LEDNipple01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nipple Disorder

Keywords

nipple fissure

Outcome Measures

Primary Outcomes (1)

• Nipple fissure

  Nipple fissure will be evaluate with digital calipers - Black Bull Scale

  1 week

Study Arms (2)

Led Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Led Therapy 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.

Led Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of psychological disorder
• Presence of mastitis
• Bacterial or fungal infection in breasts
• Use of breast pump or plastic nipple

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Mandaqui Hospital

São Paulo, São Paulo, 02401400, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistic analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 12, 2018
• Study Start: August 20, 2018
• Primary Completion: September 20, 2018
• Study Completion: August 20, 2019
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)