Effect of Topical Oxygen and LED Light Therapy on Nipple Crack

May 23, 2026 updated by: Elif Dogan, Istanbul University - Cerrahpasa

Effect of Topical Oxygen and LED Light Therapy on Nipple Crack: A Randomized Controlled Trial

The World Health Organization and UNICEF define the protection and support of breastfeeding as one of the key determinants of maternal and newborn health. Nipple cracks are common in the postpartum period and cause breastfeeding problems. If not addressed early, they can lead to interrupted or complete cessation of breastfeeding. It is important to develop methods for effective, safe, and mother-friendly care of nipple cracks. Various care approaches, such as lanolin, natural products, and hydrogels, have been described in the literature. However, evidence for non-invasive agents that support wound healing at the cellular level is limited. Evidence for LED light application is limited, and there is no evidence regarding the effect of topical oxygen application on nipple cracks.

This project is designed as a randomized controlled trial to investigate the effect of topical oxygen and LED light therapy applied to nipple cracks on wound healing, pain, and breastfeeding success. The study will be conducted at the Lactation Unit of Istanbul Haseki Training and Research Hospital, Ministry of Health, between March and December 2026. The sample size was calculated using the G*Power program; with an effect size of 0.20, a significance level of 5%, and a power of 80%, a total of 51 mothers will be included in the study. Participants will be divided into three groups using the block randomization method: Topical Oxygen (n=17), LED Light Therapy (n=17), and Control (n=17). Standard breastfeeding counseling will be provided to all groups. In addition to the intervention groups, topical oxygen will be applied at a flow rate of 10 liters per minute for 20 minutes; LED light therapy will be applied at 630 nm red and 850 nm infrared wavelengths, at an energy dose of 15.3 J/cm², for 5 minutes. Interventions will be performed on days 0, 3, and 7. Data will be collected using a personal information form, wound size measurement, Nipple Trauma Score, Visual Analog Scale, and LATCH score. The validity and reliability of the Nipple Trauma Score in Turkish will be assessed within the scope of the project.

To reduce measurement and analysis bias, support will be obtained from an independent observer and a statistician.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 18-40,
  • Those who gave birth at term (37-42 weeks),
  • Those whose baby was 0-28 days old at the first visit,
  • Those diagnosed with nipple fissures,
  • Breastfeeding their baby,
  • Those who have had a single birth,
  • Those without a diagnosis of psychiatric illness and who are not taking related medication.

Exclusion Criteria:

  • Those with infection, mastitis, abscess, etc. accompanying nipple injury,
  • Those who have started medical treatment for nipple injury,
  • Those who are unable to continue breastfeeding,
  • Those who feed their baby by expressing breast milk,
  • Those who show any adverse reaction to photosensitivity or exposure to sunlight.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Topical oxygen therapy group
Procedure: Topical oxygen therapy

Topical oxygen will be applied directly to the nipple crack using an oxygen mask. The oxygen mask will be washed and dried before and after use. The mask, which is specific to the individual, will be stored in a transparent, sealed plastic bag until it is reused.

In the literature, free-flow oxygen applications are frequently administered at a rate of 5-15 liters/min for 10-180 minutes.

The size of the nipple fissure is smaller than most wound types reported in the literature. Therefore, considering the wound size and the need to avoid long application times that would compromise maternal comfort, the therapeutic dose was adjusted accordingly. In line with this, after consulting a surgical specialist, it was planned to administer one session at a flow rate of 10 liters per minute for 20 minutes. The determined application parameters will be tested in a pilot study.
Experimental: LED light therapy group
Device: LED light therapy
An LED light device based on the photobiomodulation principle, commonly used in clinical dermatology applications, will be used in LED light therapy. The LED light will be applied directly to the nipple crack. The device is recommended to be used at a distance of 3 inches (~8 cm). The application time was determined by calculating the formulation used in similar studies in the literature: Time (sec) = Energy dose (J/cm²) ÷ Light intensity (W/cm²). Thus, the ideal duration for the device to be used was determined to be 300 seconds (5 minutes), as 15.3 J/cm² ÷ 0.051 W/cm². LED light will only be applied to Group B and a total of three times (day 0, day 3, day 7).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nipple Trauma Severity
Time Frame: Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)
Nipple trauma severity will be assessed using the Nipple Trauma Score (NTS), which evaluates breastfeeding-related nipple tissue damage based on objective observational criteria. The scale categorizes nipple changes into six severity levels scored from 0 to 5, with higher scores indicating more severe nipple trauma. The Turkish version of the scale will be developed and used in this study.
Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)
Nipple Pain Intensity
Time Frame: Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)
Nipple pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm subjective pain scale ranging from 0 (no pain) to 10 (unbearable pain). Participants will indicate the intensity of pain related to nipple trauma by marking the scale, with higher scores reflecting greater pain severity.
Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Effectiveness (LATCH Score)
Time Frame: Day 1 (pre- and post-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)
Breastfeeding effectiveness will be evaluated using the LATCH Breastfeeding Assessment Tool, which assesses latch, audible swallowing, nipple type, maternal comfort, and need for assistance. Each component is scored from 0 to 2, yielding a total score range of 0 to 10, with higher scores indicating more effective breastfeeding.
Day 1 (pre- and post-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)
Infant Weight Change
Time Frame: Day 1 (pre-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)
Infant weight will be measured using a calibrated digital infant scale to assess changes in body weight over time. Weight measurements will be recorded in grams, and changes in infant weight will be used as an indicator of early feeding adequacy.
Day 1 (pre-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/xxx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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