NCT05948150

Brief Summary

The research is a randomised controlled experimental study. It was conducted to examine the effect of breastfeeding pillow on breastfeeding self-efficacy and postnatal comfort in primiparous puerperas who gave birth by caesarean section. The answers to the questions "Is the breastfeeding pillow effective on breastfeeding self-efficacy in primiparous puerperium giving birth by caesarean section?" and "Is the breastfeeding pillow effective on comfort during breastfeeding in primiparous puerperium giving birth by caesarean section?" are investigated. The puerperas in the experimental group were allowed to use a breastfeeding pillow during breastfeeding and evaluated at 24th and 48th hours. Puerperas in the control group continued routine breastfeeding and did not use a breastfeeding pillow. They were evaluated at 24th and 48th hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 29, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

BreastfeedingExclusive Breast MilkPatient ComfortSelf-efficacy

Outcome Measures

Primary Outcomes (2)

  • Increasing breastfeeding self-efficacy by using a nursing pillow

    Increasing breastfeeding self-efficacy in puerperant women who gave birth by using a nursing pillow

    48 hours

  • Increasing postpartum comfort by using a nursing pillow

    Increasing postpartum comfort in postpartum women who gave birth by using a nursing pillow

    48 hours

Study Arms (2)

group not to use a breastfeeding pillow

EXPERIMENTAL

In this arm, individuals are not provided with a breastfeeding pillow.

Other: not using a breastfeeding pillow

breastfeeding pillow group

EXPERIMENTAL

In this arm, breastfeeding pillows are used for individuals

Other: using a breastfeeding pillow

Interventions

To make the breastfeeding pillow group use the breastfeeding pillow from the 8th hour in the postnatal period and to make evaluations at 24 and 48 hours

breastfeeding pillow group

The non-breastfeeding pillow group was evaluated at 24 and 48 hours without the use of a breastfeeding pillow

group not to use a breastfeeding pillow

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Graduated from primary school
  • No communication problems
  • The desire to breastfeed your baby,
  • The mother and the baby do not have any health condition that may prevent breastfeeding,
  • First pregnancy,
  • Having given birth at 37\> 37 weeks of gestation,
  • Having a baby weighing at least 2500 g,
  • Over 18 years of age,
  • Caesarean section with a single healthy baby

You may not qualify if:

  • having given birth more than once
  • Under 18 years of age
  • communication problems
  • unhealthy baby birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital

Erzincan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • İltifat H Dinç

    humeyra.dinc@erzincan.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Quantitative
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 17, 2023

Study Start

November 29, 2022

Primary Completion

May 30, 2023

Study Completion

June 23, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Locations