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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05624047
Other study ID # SOZKANSAT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date August 12, 2023

Study information

Verified date August 2023
Source Bitlis Eren University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to determine the effect of breastfeeding education given to pregnant women by a hybrid simulation method in the antenatal period on postpartum breastfeeding. This study will be carried out in a family health center in Turkey. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient in the intervention group. Women in the control group will receive only routine breastfeeding education.


Description:

The research will be conducted as a randomized controlled trial. The stratified block randomization methods will be used to assign women to the intervention and control groups. The personal information form and Breastfeeding Self-Efficacy Scale Short Form (Antenatal) will be implemented to all women before the intervention. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient to support women in breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education will be given to women in the 32-36 weeks of pregnancy in the antenatal period. The control group will be received the routine antenatal breastfeeding education given to all women by healthcare personnel as part of the family health center procedures. The Breastfeeding Self-Efficacy Scale Short Form (Postnatal) and the LATCH Breastfeeding Assessment Tool will be administered to women in both the experimental and control groups within the postpartum fifth days and at sixth week postpartum.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 12, 2023
Est. primary completion date August 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - being between 32-36 weeks of pregnancy - being primipara or multipara - being at least literate - being planning to breastfeed - agreeing to participate in the study Exclusion Criteria: - having a physical or mental health problem that would prevent breastfeeding - preterm labor (before 37 weeks) - either mother or baby having a health problem after birth - being with multiple pregnancy - being with high-risk pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Breastfeeding education using hybrid simulation method
In addition to the verbal breastfeeding training given to the pregnant women assigned to the experimental group, breastfeeding training will be given using the hybrid simulation method consisting of a wearable breast model and standard patient practice.
Routine verbal breastfeeding education
Women in this group will receive oral breastfeeding training, which is routinely given in the pregnant education class and consists of one session.

Locations

Country Name City State
Turkey Bitlis Hüsrevpasa Family Center Bitlis

Sponsors (1)

Lead Sponsor Collaborator
Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Breastfeeding Self-Efficacy Scale-Short Form (Antenatal) The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception. Baseline: Between 32 and 36 weeks of pregnancy
Primary The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal) The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception. Postpartum on the fifth day
Primary The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal) The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception. Postpartum 6th week
Primary LATCH Breastfeeding Assesment Tool The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The higher score indicates a higher breastfeeding. success. Postpartum on the fifth day
Primary LATCH Breastfeeding Assesment Tool The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The higher score indicates a higher breastfeeding. success. Postpartum 6th week
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