NCT06009120

Brief Summary

Breastfeeding education based on the theory of psychosexual development is important as it addresses the social and psychological significance of childhood and the impact of early childhood experiences on later social anxieties and psychosexual well-being. However, no theory-based breastfeeding education given to the mothers was found in the literature. Therefore, the study aimed to investigate the effect of breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers, in line with the theory of psychosocial development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

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

December 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 18, 2023

Last Update Submit

August 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • IOWA Infant Feeding Attitude Scale

    The scale was developed by De La Mora et al. in 1999 to assess the attitudes of women towards breastfeeding and to predict the choice of infant feeding method as well as the duration of breastfeeding. The total attitude score ranges from 17 (indicating a positive attitude towards bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding).

    1 WEEK

  • Breastfeeding Form

    This form was created by the researchers to evaluate the mothers' experiences of breastfeeding and using formula for one week after birth. The form includes four questions about breastfeeding frequency \& duration and formula use \& frequency from day to day.

    1 WEEK

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention (education) group: In addition to the standard discharge education, mothers in this group received breastfeeding education.

Other: Education

Control

NO INTERVENTION

Control group: In this group, first of all, mothers were informed about the study within the first day after birth, and informed consent forms were signed by those who voluntarily agreed to participate. In addition, "Personal Information Form", "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Information Scale" were applied to these mothers on the first day. Then, as the routine care of the institution, the standard discharge education program on the third day was applied by the institution nurse. After this education, "IOWA Infant Feeding Attitude Scale" and "Psychosexual Theory and Breastfeeding Knowledge Form" were re-administered to mothers as a post-test. No additional intervention was applied other than standard care education. During the 5 days following discharge, mothers were interviewed by phone and "Breastfeeding Form'' applied.

Interventions

The education program emphasized the characteristics of the oral stage, positive traits that can be acquired when the baby's needs are met during this stage, negative traits that may develop in the baby when their needs are not met, and the relationship between the oral stage and breastfeeding.

Intervention

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was carried out with mothers who gave birth, so women were studied.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • being primitive,
  • being 18 years or older,
  • having a healthy birth,
  • using a mobile phone,
  • being within 72-96 hours after birth,
  • participating in the research voluntarily.

You may not qualify if:

  • having cognitive problems,
  • delivering a premature newborn, having a baby in the neonatal intensive care unit,
  • having a health problem that would prevent her from breastfeeding the baby,
  • using any sedatives, anticonvulsants, or analgesics, don't the ability to speak Turkish,
  • giving formula to their baby for any reason within the first three days,
  • having a life-threatening illness or condition,
  • not being willing to participate in the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Savas EH, Semerci R, Eroglu K, Can N, Ozturk A. Impact of psychosexual development theory-based breastfeeding education on infant feeding attitudes and knowledge of primiparous mothers: A randomized controlled study. J Pediatr Nurs. 2024 Jul-Aug;77:e503-e510. doi: 10.1016/j.pedn.2024.05.016. Epub 2024 May 18.

MeSH Terms

Conditions

Breast Feeding

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Eyşan Hanzade UMAÇ

    Koç University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients who met the sample selection criteria were randomly divided into two groups, an intervention (education) group and a CG, using a computer-based program (www.random.org). The assignment to the intervention and CG was performed by an independent statistician. Thus, by implementing randomized allocation and concealing the randomization, selection bias was controlled. In the study, participant blinding was carried out, but researcher blinding was not possible due to the researcher's awareness of the intervention being administered. In a 1:1 ratio, the women were separated into intervention and CGs (Figure 1).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

December 1, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations