BreastfeedingNCT07370051
Effect of Topical Oxygen and LED Light Therapy on Nipple Crack
A study testing Topical oxygen therapy and LED light therapy in people with Breastfeeding and Newborn Infant, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breastfeeding, Newborn Infant, Midwifery
- What is being tested?
- Topical oxygen therapy and LED light therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul
Elif DOGAN, +90 539 601 15 88, elifdogann18@gmail.com
About this study
Official title: 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.
- Conditions
- Breastfeeding, Newborn Infant, Midwifery, Breast
- Being tested
- Topical oxygen therapy, LED light therapy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical oxygen therapyProcedure or surgery
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.
LED light therapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Topical oxygen therapy group | Experimental | Not described Receives: Procedure: Topical oxygen therapy |
| LED light therapy group | Experimental | Not described Receives: Device: LED light therapy |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)
Secondary outcomes (2)
Breastfeeding Effectiveness (LATCH Score)
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.
Measured: Day 1 (pre- and post-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)
Infant Weight Change
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.
Measured: Day 1 (pre-intervention), Day 3 (pre-intervention), and Day 7 (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dogan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370051
- Sponsor's protocol ID
- 2025/xxx
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22283620Camargo 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.
PubMed 31030379de 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.
PubMed 28783878Sykorova 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.
PubMed 38522472
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Oxygen and LED Light Therapy on Nipple Crack: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07370051
- Acronym / sponsor ID
- 2025/xxx
- Conditions
- Breastfeeding, Newborn Infant, Midwifery, Breast
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical oxygen therapy group | Experimental | Procedure: Topical oxygen therapy |
| LED light therapy group | Experimental | Device: LED light therapy |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical oxygen therapyTopical 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. | Procedure or surgery | Topical oxygen therapy group |
| LED light therapyAn 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). | Device | LED light therapy group |
Primary outcome
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.
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.
2 secondary outcomes
Breastfeeding Effectiveness (LATCH Score)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 22283620Chaves 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.
- Background: PubMed 31030379Camargo 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.
- Background: PubMed 28783878de 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.
- Background: PubMed 38522472Sykorova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical oxygen therapy and LED light therapy in people with Breastfeeding and Newborn Infant, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif DOGAN (+90 539 601 15 88, elifdogann18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple Trauma Severity (time frame: Day 1 (pre- and post-intervention), Day 3 (post-intervention), and Day 7 (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370051, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.