- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948150
The Effect of Breastfeeding Pillow on Breastfeeding Self-Efficacy and Postpartum Comfort in Women Who Had Cesarean
July 13, 2023 updated by: İltifat Hümeyra DİNÇ, Ataturk University
The Effect Of Breastfeedıng Pıllow On Breastfeedıng Self- Effıcacy And Postnatal Comfort In Prımıparous Postpartum Women Who Gave Bırth By Caesarean Sectıon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzincan, Turkey
- Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- having given birth more than once
- Under 18 years of age
- communication problems
- unhealthy baby birth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group not to use a breastfeeding pillow
In this arm, individuals are not provided with a breastfeeding pillow.
|
The non-breastfeeding pillow group was evaluated at 24 and 48 hours without the use of a breastfeeding pillow
|
Experimental: breastfeeding pillow group
In this arm, breastfeeding pillows are used for individuals
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increasing breastfeeding self-efficacy by using a nursing pillow
Time Frame: 48 hours
|
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
Time Frame: 48 hours
|
Increasing postpartum comfort in postpartum women who gave birth by using a nursing pillow
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İltifat H Dinç, humeyra.dinc@erzincan.edu.tr
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2022
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
June 23, 2023
Study Registration Dates
First Submitted
June 24, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AtaturkU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cesarean Section; Dehiscence
-
Recep Tayyip Erdogan University Training and Research...CompletedCesarean Section Complications | Cesarean Section; DehiscenceTurkey
-
Aljazeera HospitalCompleted
-
Kocaeli UniversityCompletedCesarean Section; Dehiscence | Cesarean Wound; DehiscenceTurkey
-
Ramsay Générale de SantéEuropean Clinical Trial Experts NetworkRecruitingCesarean Section; Dehiscence | Extra Peritoneal Caesarean SectionFrance
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedCesarean Section Complications | Cesarean Section; DehiscenceTurkey
-
Safak Baran YilmazCompletedCesarean Section Complications | Cesarean Section; Dehiscence | Uterine ScarTurkey
-
HealthPlus Fertility CenterRecruitingCesarean Section; Dehiscence | Reproductive Issues | Intrauterine DisorderUnited Arab Emirates
-
T.C. ORDU ÜNİVERSİTESİCompletedBreast Feeding | Self Efficacy | Cesarean Section; DehiscenceTurkey
-
Odense University HospitalHvidovre University Hospital; Smith & Nephew, Inc.; University of Southern Denmark and other collaboratorsCompletedSurgical Wound Infection | Cesarean Section; Dehiscence | Complications; Cesarean Section | Infection; Cesarean Section | Complications; Cesarean Section, Wound, Dehiscence | Wound; Rupture, Surgery, Cesarean SectionDenmark
-
Piazza della Vittoria 14 Studio Medico - Ginecologia...CompletedCesarean Section Complications | Cesarean Wound; DehiscenceItaly
Clinical Trials on not using a breastfeeding pillow
-
Taipei Medical UniversityCompletedPregnancy Related | Safety Issues | Breastfeeding | Newborn; FitTaiwan
-
Trakya UniversityCompletedSleep | Comfort | PreoperativeTurkey
-
Bitlis Eren UniversityCompleted
-
Istanbul University - Cerrahpasa (IUC)Istinye UniversityActive, not recruitingEducation | Newborn; Vitality | Breastfeeding EducationTurkey
-
DeRoyal Industries, Inc.Lincoln Memorial UniversityCompletedHeel Pressure Ulceration Prevention StrategiesUnited States
-
Sakarya UniversityNot yet recruiting
-
Baylor College of MedicineCenters for Disease Control and PreventionCompleted
-
University Hospital, LimogesCompleted
-
Makerere UniversityCharite University, Berlin, GermanyNot yet recruitingHIV Infections | COPD | Respiratory DiseaseUganda