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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05697653
Other study ID # Nursing123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 18, 2019
Est. completion date May 5, 2021

Study information

Verified date December 2022
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to the separation of the mother and the baby after the cesarean section, initiation of breastfeeding by the mother of the newborn in the first hour of life is delayed. The rate of cesarean section in Turkey has increased to 52%, according to the 2019 data of the Center for Disease Control and Prevention, the rate of cesarean section has increased to 31.7% in the world and up to 65% in the USA. It has been reported in the literature that cesarean deliveries are performed with general, spinal and epidural anesthesia types, and the Apgar scores of newborns after cesarean section performed with spinal and epidural anesthesia are high. In this context, the nurse has a key role in initiating and maintaining breastfeeding after early SSC between the mother and the newborn within the first hour following the cesarean section performed with spinal anesthesia. In the literature, there are studies reporting that skin-to-skin contact applied after normal delivery increases the sucking success of newborns, the successful breastfeeding rate, and the rate of exclusive breastfeeding. There are studies examining the effect of early skin-to-skin contact applied after cesarean section on the suckling success of the newborn and only breastfeeding. Breastfeeding self-efficacy refers to a woman's confidence in her ability to breastfeed her baby. It is reported in the literature that skin-to-skin contact and only breastfeeding education have an effect on breastfeeding self-efficacy.


Description:

Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method. Independent variable: Skin-to-skin contact. Dependent variables: Sucking efficacy of newborns and breastfeeding self-efficacy of mothers. Research Hypotheses; H1: Skin-to-skin contact applied after cesarean deliveries performed with spinal anesthesia has an effect on the sucking efficiency of newborns. H2: Skin-to-skin contact applied after cesarean section with spinal anesthesia has an effect on breastfeeding self-efficacy of mothers It was performed with a total of 72 women and newborns (37 interventions, 35 control groups) who had a cesarean section with spinal anesthesia in a Training and Research Hospital Gynecology Service in the West of Turkey. Data were collected using the "Newborn and Parent Information Form", "Breastfeeding Self-Efficacy Short Form Scale" and "LATCH Scale".


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 5, 2021
Est. primary completion date March 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Hour to 30 Days
Eligibility Inclusion Criteria: Mothers; - Planning of cesarean section with spinal anesthesia - Being between the ages of 18- 45 - Having a singleton pregnancy - Gestational week is between 37-40 weeks - Absence of any known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.) - Agreeing to participate in the study - Before the skin-to-skin contact procedure, their general condition and vital signs should be checked to be stable - Being a resident of Kütahya Newborns (0-28 days); - Gestational age between 37-40 weeks - Birth weight between 2500-4500 g - 1.-5. minute Apgar Score = 7 - Absence of any health problems, anomalies or congenital diseases - Absence of obstacles to sucking such as frenulum (tongue-tie) or palate problem Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Skin-to-Skin contact.
Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kutahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of skin-to-skin contact on breastfeeding self efficacy of mothers "Breastfeeding Self-Efficacy Scale Short Form" was used to determine mothers' breastfeeding self-efficacy.
A high score from the scale indicates that the mother's breastfeeding self-efficacy is high.
through study completion, an average of 1 year
Primary The effect of skin-to-skin contact on breastfeeding success of mothers and sucking success of newborns. "LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on breastfeeding success of mothers and breastfeeding success of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success.
The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)].
through study completion, an average of 1 year
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