Nipple Pain During LactationNCT07082959
The Effect of Nursing Pillow Use on Nipple Pain and Comfort
A study testing Nursing Pillow in people with Nipple Pain During Lactation and Comfort, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Many factors influence breastfeeding. Nipple pain and comfort are among these factors and can negatively impact the breastfeeding process. A nursing pillow can relieve nipple pain and increase comfort. The purpose of this study was to evaluate the effects of breastfeeding pillow use on nipple pain and comfort. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nipple Pain During Lactation, Comfort
- What is being tested?
- Nursing Pillow
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2025to 1 Apr 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who gave birth at 37 weeks of gestation or later
- Women who had a vaginal delivery
- Primiparous women
- Women whose babies weigh 2500 grams or more
- Women who are willing to breastfeed their babies
- Women who can speak and understand Turkish
Who cannot join
- Women who gave birth to twins or more
- Women with previous breastfeeding experience
- Women who experienced postpartum complications
- Women with conditions that may prevent breastfeeding
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-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Prof. Dr. Murat Dilmener Hospital
Istanbul, Bakırköy, 34140
About this study
Official title: The Effect of Nursing Pillow Use on Nipple Pain and Comfort in the Postpartum Period
Many factors influence breastfeeding. Nipple pain and comfort are among these factors and can negatively impact the breastfeeding process. A nursing pillow can relieve nipple pain and increase comfort. The purpose of this study was to evaluate the effects of breastfeeding pillow use on nipple pain and comfort.
Read the detailed description
This study was planned to determine the effect of using a breastfeeding pillow in the postpartum period on nipple pain and maternal comfort. The breastfeeding process is a crucial period not only for ensuring the newborn's adequate nutrition but also for strengthening the bond between mother and baby. The World Health Organization (WHO) and UNICEF recommend initiating breastfeeding within the first hour after birth, exclusively breastfeeding for the first six months, and continuing breastfeeding up to two years of age. However, the sustainability of this process is directly related to the mother's physical comfort and the challenges she encounters.
Nipple pain is one of the most common problems during the breastfeeding period. It is often caused by improper latching of the baby and is one of the leading reasons for early cessation of breastfeeding. Additionally, the mother's inability to maintain a proper body position while breastfeeding may lead to physical discomforts such as back and waist pain, negatively affecting her level of comfort.
In this context, breastfeeding pillows are assistive tools designed to help mothers maintain an appropriate position during breastfeeding, aiming to reduce nipple pain and increase comfort. Although there are studies on the positive effects of breastfeeding pillows on breastfeeding success, comfort, and maternal-infant outcomes, no study has been found that specifically investigates the effect of using a breastfeeding pillow in the postpartum period on nipple pain and maternal comfort in women who had a vaginal delivery.
Therefore, the aim of this study is to evaluate the effect of breastfeeding pillow use during the postpartum period on nipple pain and maternal comfort.
- Conditions
- Nipple Pain During Lactation, Comfort
- Being tested
- Nursing Pillow
- Keywords
- Breastfeeding, Nursing pillow, Nipple pain, Comfort, Postpartum period
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing PillowBehavioural
Although there are studies investigating the effects of breastfeeding pillow use on breastfeeding success, comfort, and positive outcomes for both mother and baby, no study has been found examining the effect of breastfeeding pillow use on nipple pain and maternal comfort in women who have undergone vaginal delivery. Therefore, the aim of this study is to evaluate the effect of breastfeeding pillow use on nipple pain and comfort during the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Use of a breastfeeding pillow during the postpartum period to evaluate nipple pain and comfort. Receives: Behavioral: Nursing Pillow |
| Control Group | No intervention | Participants in this group will receive routine postpartum care without a breastfeeding pillow. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple Pain
The intensity of nipple pain experienced by mothers during breastfeeding measured by Visual Analog Scale (VAS).
Measured: It will be evaluated within the first 24 hours postpartum and on the 7th day.
Secondary outcomes (1)
Comfort
Maternal comfort during breastfeeding assessed using the Postpartum Comfort Scale.
Measured: The Postpartum Comfort Scale is a validated tool consisting of 34 items rated on a 5-point Likert scale. It evaluates physical, psychospiritual, and sociocultural comfort. It will be evaluated within the first 24 hours postpartum and on the 7th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start18 Aug 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple Pain During LactationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Postpartum women will be randomly divided into two groups at a 1:1 ratio, with the intervention group using a breastfeeding pillow, while the control group will not receive any intervention and will continue their routine care.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Tanrıkulu, Istanbul University - Cerrahpasa
- Investigators
- Tülay TÜLAY Yılmaz, Associate Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082959
- Sponsor's protocol ID
- IUC-SBF-TT-01
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Pillow Use on Nipple Pain and Comfort in the Postpartum Period
- ClinicalTrials.gov ID
- NCT07082959
- Acronym / sponsor ID
- IUC-SBF-TT-01
- Conditions
- Nipple Pain During Lactation, Comfort
- Keywords
- Breastfeeding, Nursing pillow, Nipple pain, Comfort, Postpartum period
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
Many factors influence breastfeeding. Nipple pain and comfort are among these factors and can negatively impact the breastfeeding process. A nursing pillow can relieve nipple pain and increase comfort. The purpose of this study was to evaluate the effects of breastfeeding pillow use on nipple pain and comfort.
Detailed description
This study was planned to determine the effect of using a breastfeeding pillow in the postpartum period on nipple pain and maternal comfort. The breastfeeding process is a crucial period not only for ensuring the newborn's adequate nutrition but also for strengthening the bond between mother and baby. The World Health Organization (WHO) and UNICEF recommend initiating breastfeeding within the first hour after birth, exclusively breastfeeding for the first six months, and continuing breastfeeding up to two years of age. However, the sustainability of this process is directly related to the mother's physical comfort and the challenges she encounters.
Nipple pain is one of the most common problems during the breastfeeding period. It is often caused by improper latching of the baby and is one of the leading reasons for early cessation of breastfeeding. Additionally, the mother's inability to maintain a proper body position while breastfeeding may lead to physical discomforts such as back and waist pain, negatively affecting her level of comfort.
In this context, breastfeeding pillows are assistive tools designed to help mothers maintain an appropriate position during breastfeeding, aiming to reduce nipple pain and increase comfort. Although there are studies on the positive effects of breastfeeding pillows on breastfeeding success, comfort, and maternal-infant outcomes, no study has been found that specifically investigates the effect of using a breastfeeding pillow in the postpartum period on nipple pain and maternal comfort in women who had a vaginal delivery.
Therefore, the aim of this study is to evaluate the effect of breastfeeding pillow use during the postpartum period on nipple pain and maternal comfort.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Postpartum women will be randomly divided into two groups at a 1:1 ratio, with the intervention group using a breastfeeding pillow, while the control group will not receive any intervention and will continue their routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Nursing PillowUse of a breastfeeding pillow during the postpartum period to evaluate nipple pain and comfort. |
| Control Group | No intervention | –Participants in this group will receive routine postpartum care without a breastfeeding pillow. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women who gave birth at 37 weeks of gestation or later
- Women who had a vaginal delivery
- Primiparous women
- Women whose babies weigh 2500 grams or more
- Women who are willing to breastfeed their babies
Key exclusion criteria (4 listed)
- Women who gave birth to twins or more
- Women with previous breastfeeding experience
- Women who experienced postpartum complications
- Women with conditions that may prevent breastfeeding
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 |
|---|---|---|
| Nursing PillowAlthough there are studies investigating the effects of breastfeeding pillow use on breastfeeding success, comfort, and positive outcomes for both mother and baby, no study has been found examining the effect of breastfeeding pillow use on nipple pain and maternal comfort in women who have undergone vaginal delivery. Therefore, the aim of this study is to evaluate the effect of breastfeeding pillow use on nipple pain and comfort during the postpartum period. | Behavioural | Intervention Group |
Primary outcome
Nipple Pain
Time frame: It will be evaluated within the first 24 hours postpartum and on the 7th day.
The intensity of nipple pain experienced by mothers during breastfeeding measured by Visual Analog Scale (VAS).
1 secondary outcome
Comfort
Time frame: The Postpartum Comfort Scale is a validated tool consisting of 34 items rated on a 5-point Likert scale. It evaluates physical, psychospiritual, and sociocultural comfort. It will be evaluated within the first 24 hours postpartum and on the 7th day.
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 28 Jul 2025.
- Individual participant dataSharing planned: No
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.
Tülay TÜLAY Yılmaz, Associate Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Pillow in people with Nipple Pain During Lactation and Comfort, 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 6 inclusion and 4 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 28 Jul 2025. 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 Tuğba TUĞBA Tanrıkulu, Undergraduate (+905531452958, tugbattanrikulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple Pain (time frame: It will be evaluated within the first 24 hours postpartum and on the 7th day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.