Effect of Topical Oxygen and LED Light Therapy on Nipple Crack

NCT07370051 | Not Yet Recruiting

• 1 other identifier: 2025/xxx
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Newborn Infant; Midwifery; Breast

Outcome Measures

Primary Outcomes (2)

• Nipple Trauma Severity

  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

  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 Outcomes (2)

• Breastfeeding Effectiveness (LATCH Score)

  Day 1 (pre- and post-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)

• Infant Weight Change

  Day 1 (pre-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)

Study Arms (3)

Topical oxygen therapy group

EXPERIMENTAL

Procedure: Topical oxygen therapy

LED light therapy group

EXPERIMENTAL

Device: LED light therapy

Control group

NO INTERVENTION

Interventions

Topical oxygen therapy PROCEDURE

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.

Topical oxygen therapy group

LED light therapy DEVICE

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).

LED light therapy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Eligibility is limited based on biological sex, as the study includes postpartum individuals who have given birth and are breastfeeding.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Chaves ME, Araujo AR, Santos SF, Pinotti M, Oliveira LS. LED phototherapy improves healing of nipple trauma: a pilot study. Photomed Laser Surg. 2012 Mar;30(3):172-8. doi: 10.1089/pho.2011.3119. Epub 2012 Jan 27.

  PMID: 22283620 BACKGROUND

• Camargo BTS, Coca KP, Amir LH, Correa L, Aranha ACC, Marcacine KO, Abuchaim ESV, Abrao ACFV. The effect of a single irradiation of low-level laser on nipple pain in breastfeeding women: a randomized controlled trial. Lasers Med Sci. 2020 Feb;35(1):63-69. doi: 10.1007/s10103-019-02786-5. Epub 2019 Apr 27.

  PMID: 31030379 BACKGROUND

• de Smet GHJ, Kroese LF, Menon AG, Jeekel J, van Pelt AWJ, Kleinrensink GJ, Lange JF. Oxygen therapies and their effects on wound healing. Wound Repair Regen. 2017 Aug;25(4):591-608. doi: 10.1111/wrr.12561. Epub 2017 Aug 7.

  PMID: 28783878 BACKGROUND

• Sykorova M, Moffatt CJ, Stentiford N, Burian EA, Katsuhiro S, Wei Y. Topical oxygen therapy and singlet oxygen in wound healing: A scoping review. Int Wound J. 2024 Apr;21(4):e14846. doi: 10.1111/iwj.14846.

  PMID: 38522472 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

Elif DOGAN

CONTACT

+90 539 601 15 88; elifdogann18@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)