Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05433818 |
| Other study ID # |
E-41997688-050.99-26938 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2022 |
| Est. completion date |
May 15, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Kutahya Health Sciences University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin
contact on breastfeeding efficiency and maternal attachment.
Design: This study was planned as a three-group randomized controlled study. Setting and
participants: This study will conduct with 92 women in a delivery room in Turkey between
October 2021 and May 2022.
Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A),
breastfeeding education (Group B), and control groups (Group C). Group A received SSC
education and Group B received structured breastfeeding education.
Description:
Primiparous women in the latent phase will given detailed information about the study
(purpose and benefits of the study) and the pregnant women will invited to the study.
Pregnant women will assigned to one of three groups (1:1:1) as A, B, and C in the
www.randomizer.org program. Prior to the interventions, the Mother-Infant Information Form
and MAI will applied to the pregnant women. After the interventions, MAI and BBAT will
applied at an appropriate time when the participants felt most comfortable and rested and
their perceptions will clear (4-6 hours postpartum). Eventually, the study sample will
composed of 93 pregnant women based on the CONSORT 2010 (http://www.consort-statement.org/)
flow diagram: 31 participants in Group A, and 31 in the Groups B, C (Figure 1).
SSC (Group-A) Pregnant women will assigned to Group A will informed about SSC. SSC will
ensured postpartum in a supported diagonal-flexion position continuously by the researchers
for 45-120 minutes. Mothers in group A will also benefit from the hospital's routine
breastfeeding education service.
Structured Breastfeeding Education Program (Group-B) Structured breastfeeding education
material will prepared to increase breastfeeding awareness and level of knowledge. Opinions
will received from 7 different experts for the education booklet and brochure. The material
will revised based on expert opinions. A brochure and educational material will administered
to 10 pregnant women before the study and the material will found to be understandable. The
education booklet include breastfeeding techniques, the benefits of breast milk, the benefits
of breastfeeding, solution suggestions for breastfeeding problems, lactation mechanism, and
storage of breast milk. The breastfeeding brochure include educational texts, educators'
contact information, and pictures.
Group B will receive face-to-face breastfeeding education in the first phase of labor. A copy
of the brochure will given to the pregnant women. In the early postpartum period,
breastfeeding will encouraged practically and observed by the researchers. Participants'
questions will answered.
Control (Group-C) No intervention will made to Group C by the researchers. Participants
benefite from the hospital's routine care and breastfeeding education services. Posttests
will applied in a way that would not interrupt the routine care and education practices of
the hospital.
