- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697653
Effect of Skin to Skin Contact on Sucking Efficiency of Newborns and Breastfeeding Self Efficacy of Mothers in Cesarean Deliveries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kutahya, Turkey
- Kütahya Health Sciences University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group (skin-to-skin contact group)
skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on.
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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.
|
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No Intervention: control group
The routine applications of the hospital were applied to the pregnant women in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of skin-to-skin contact on breastfeeding self efficacy of mothers
Time Frame: through study completion, an average of 1 year
|
"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
|
|
The effect of skin-to-skin contact on breastfeeding success of mothers and sucking success of newborns.
Time Frame: through study completion, an average of 1 year
|
"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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Nursing123
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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