The Effect of Breastfeeding Education Given to Family Members on Breastfeeding Parameters

Sponsor
Selcuk University (Other)
Overall Status
Completed
CT.gov ID
NCT06119828
Collaborator
(none)
133
1
1
15.9
8.4

Study Details

Study Description

Brief Summary

The Effect of Breastfeeding Education Given to Family Members Who Support the Mother in the Postpartum Period on Breastfeeding Parameters. Istanbul University-Cerrahpaşa Graduate Education Institute, Midwifery Department. Doctoral Thesis. Istanbul.

I To examine the effect of breastfeeding education given to family members in the postpartum period on breastfeeding parameters. It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters

Condition or Disease Intervention/Treatment Phase
  • Behavioral: breastfeeding education for family members
  • Other: receiving routine breastfeeding training
N/A

Detailed Description

Power analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation. Considering that there may be losses during the study process, the sample size was increased by 20% and it was decided to include at least 77 people in each group. The calculation of the sample size was based on Zeliha Burcu Baysal's doctoral thesis titled The Effect of Breastfeeding Education and Counseling Given to Pregnant Women and Their Spouses on the Breastfeeding Process and Attachment.

The main aims of the study are:

Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month? In the intervention group, family members will be given breastfeeding education and they will be asked to support mothers in the postpartum period.

In the comparison group, no breastfeeding education was given to the family member.

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters.It was conducted as a randomized controlled experimental study to determine the effect of breastfeeding education given to the family member who supports the mother in the postpartum period on breastfeeding parameters.
Masking:
None (Open Label)
Masking Description:
Since one researcher conducted the study, blinding was not possible.
Primary Purpose:
Supportive Care
Official Title:
THE EFFECT OF BREASTFEEDING EDUCATıON ON BREASTFEEDING PARAMETERS GIVEN TO FAMILY MEMBERS PROVIDING SUPPORT TO THE MOTHER IN THE POSTPARTUM PERİOD
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parallel Asignment

Power analysis was performed using the G*Power(v3.1.9) program to determine the sample size. The power of the study is expressed as 1-β (β = probability of type II error) and in general, studies must have 80% power. According to the effect size coefficients determined by Cohen, assuming that the evaluations to be made between two independent groups will have a medium effect size (d = 0.5), α = 0.05 and β = 0.20, it was determined that there should be at least 64 people in each group, according to the calculation.

Behavioral: breastfeeding education for family members
The first breastfeeding skills of mothers who gave birth in the delivery room and the first breastfeeding skills after birth were evaluated using BEDÖ. After giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. After the mothers' 1-hour breastfeeding was evaluated in the delivery room, the training phase of family members began. CBT was administered to family members in the waiting room before the training, which lasted approximately 7-8 minutes. Then, breastfeeding training was given to family members for 20-25 minutes. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. On the 15th postpartum day, the family member was called by phone and reminded about breastfeeding education. At the first month postpartum,Checklist were administered to the mother via telephone conversation
Other Names:
  • education
  • Other: receiving routine breastfeeding training
    After giving birth, mothers were taken to the maternity ward after being kept under control in the delivery room for 2 hours. Mothers' breastfeeding was evaluated at the 1st hour in the delivery room. CBT was administered to family members in the waiting room. BBST was applied after the mother transferred to the maternity ward. Before the mother and the baby were discharged from the hospital, BEDÖ and BBTÖ were administered to the family member. At the first month postpartum, BBTÖ was administered to the family member, and BBTÖ and EÖY scale and Breastfeeding Checklist were administered to the mother over the phone.
    Other Names:
  • Control groups
  • Outcome Measures

    Primary Outcome Measures

    1. breastfeeding education given to family members [postpartum 1st month]

      Breastfeeding education given to the family member; Does it increase the rate of mothers starting breastfeeding? Breastfeeding education given to the family member; Does it increase the rate of mothers giving exclusive breastfeeding in the first month?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    For mothers;

    • Will receive support from a family member during the postpartum period,

    • Having an uncomplicated pregnancy and birth history,

    • No multiple pregnancy,

    • Not giving birth before the 37th week of pregnancy,

    • Not having any disease that prevents breastfeeding in the postpartum period (undergoing chemotherapy, active tuberculosis, using drugs that prevent breastfeeding, etc.),

    • Spending the pregnancy period and the first month after birth in the area where the research will be conducted,

    • Being at least a primary school graduate,

    • No communication problems,

    • Being primiparous or multiparous with breastfeeding problems,

    • For the family member who will provide support to the mother in the postpartum period, as long as the baby does not have any health problems that prevent breastfeeding;

    • Spending time with the mother regularly for at least 1 hour at least five days a week during the postpartum period,

    • Being able to communicate in Turkish,

    • It was defined as residing in the same city during the period when the research data was collected.

    Exclusion Criteria:

    For mothers;

    • Those with a history of complicated pregnancy and birth,

    • Those with multiple pregnancies,

    • Those with premature babies,

    • Conditions related to mother and baby that prevent breastfeeding in the postpartum period (pregnancy psychosis, congenital anomaly, sucking and swallowing coordination disorder, etc.),

    • Those who will not live in the area where the research will be conducted during pregnancy and the first month after birth,

    • Those who have difficulty communicating for various reasons (not being able to speak Turkish, serious hearing problems, etc.)

    • Mothers who did not meet the research criteria for any reason after being included in the study (interventional birth, the baby having any disease requiring hospitalization in neonatal intensive care, etc.) were excluded from the scope of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SelcukUniversity Konya Turkey 42250

    Sponsors and Collaborators

    • Selcuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cevriye Ocaktan Tetikçok, Research assistant, Selcuk University
    ClinicalTrials.gov Identifier:
    NCT06119828
    Other Study ID Numbers:
    • 2019/706
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cevriye Ocaktan Tetikçok, Research assistant, Selcuk University

    Study Results

    No Results Posted as of Nov 7, 2023