NCT07370051

Effect of Topical Oxygen and LED Light Therapy on Nipple Crack

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2026-03-15
• Primary completion: 2027-03-15
• Completion: 2027-04-15
• First posted: 2026-01-27
• Last updated: 2026-01-30

Locations

1 site across 1 country: Turkey (Türkiye)