NCT07082959

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 17, 2025

Last Update Submit

July 24, 2025

Conditions

Nipple Pain During LactationComfort

Keywords

BreastfeedingNursing pillowNipple painComfortPostpartum period

Outcome Measures

Primary Outcomes (1)

  • Nipple Pain

    The intensity of nipple pain experienced by mothers during breastfeeding measured by Visual Analog Scale (VAS).

    It will be evaluated within the first 24 hours postpartum and on the 7th day.

Secondary Outcomes (1)

  • Comfort

    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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Use of a breastfeeding pillow during the postpartum period to evaluate nipple pain and comfort.

Behavioral: Nursing Pillow

Control Group

NO INTERVENTION

Participants in this group will receive routine postpartum care without a breastfeeding pillow.

Interventions

Nursing PillowBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Prof. Dr. Murat Dilmener Hospital

Istanbul, Bakırköy, 34140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Tülay TÜLAY Yılmaz, Associate Professor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Tuğba TUĞBA Tanrıkulu, Undergraduate

CONTACT

+905531452958tugbattanrikulu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the visible and practical nature of the intervention (use of a breastfeeding pillow), neither participants nor investigators were blinded.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student with Thesis, Istanbul University-Cerrahpasa Midwifery Department

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 24, 2025

Study Start

August 18, 2025

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)