NCT07370051

Effect of Topical Oxygen and LED Light Therapy on Nipple Crack

Not yet recruiting NA Last updated 30 January 2026

What this trial tests

NA trial testing Topical oxygen therapy in Breastfeeding in 51 participants. Not yet recruiting.

Timeline

15 March 2026

Primary endpoint
15 March 2027

15 April 2027

Quick facts

Lead sponsor	Istanbul University - Cerrahpasa
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	51
Start date	15 March 2026
Primary completion	15 March 2027
Estimated completion	15 April 2027
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Topical oxygen therapy
• LED light therapy

Conditions studied

• Breastfeeding — all drugs for Breastfeeding →
• Newborn Infant — all drugs for Newborn Infant →
• Midwifery — all drugs for Midwifery →
• Breast — all drugs for Breast →

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 18 to 40, female only, with Breastfeeding or Newborn Infant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.