NCT06119828

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

Same day

First QC Date

October 27, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

family member, breastfeeding self-efficacy, nutritional attitude

Outcome Measures

Primary Outcomes (1)

  • breastfeeding education given to family members

    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?

    postpartum 1st month

Study Arms (1)

Parallel Asignment

EXPERIMENTAL

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 membersOther: receiving routine breastfeeding training

Interventions

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

Also known as: education
Parallel Asignment

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.

Also known as: Control groups
Parallel Asignment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SelcukUniversity

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (3)

  • Holbrook KE, White MC, Heyman MB, Wojcicki JM. Maternal sociodemographic characteristics and the use of the Iowa Infant Attitude Feeding Scale to describe breastfeeding initiation and duration in a population of urban, Latina mothers: a prospective cohort study. Int Breastfeed J. 2013 Jul 8;8(1):7. doi: 10.1186/1746-4358-8-7.

  • Han FL, Ho YJ, McGrath JM. The influence of breastfeeding attitudes on breastfeeding behavior of postpartum women and their spouses. Heliyon. 2023 Feb 23;9(3):e13987. doi: 10.1016/j.heliyon.2023.e13987. eCollection 2023 Mar.

  • Houghtaling B, Byker Shanks C, Ahmed S, Rink E. Grandmother and health care professional breastfeeding perspectives provide opportunities for health promotion in an American Indian community. Soc Sci Med. 2018 Jul;208:80-88. doi: 10.1016/j.socscimed.2018.05.017. Epub 2018 May 8.

MeSH Terms

Conditions

Breast Feeding

Interventions

Educational StatusControl Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Since one researcher conducted the study, blinding was not possible.
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 7, 2023

Study Start

January 1, 2021

Primary Completion

January 1, 2021

Study Completion

April 30, 2022

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

There are no plans for use by other workers.

Locations