NCT05812833

Brief Summary

Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

April 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

August 3, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Meleis Transition Theoryinfant healthonline educationweb page

Outcome Measures

Primary Outcomes (2)

  • Education

    Web-based online baby care training based on Meleis' Transition Theory to measures mothers' self-confidence

    16 weeks

  • Newborn

    To evaluate more successful breastfeeding in infants of mothers who received web-based online infant care training based on Meleis' Transition Theory.

    16 weeks

Study Arms (2)

Participating in online training and providing active consultancy

EXPERIMENTAL

Online training will be given to mothers, and then the web link will be shared and online counseling will be given every week. Mothers will be followed for 3 months

Behavioral: Education

Control

NO INTERVENTION

Will receive routine maintenance of the institution

Interventions

EducationBEHAVIORAL

Pregnant women will be given online baby care training

Also known as: consultancy
Participating in online training and providing active consultancy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMother
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous pregnant
  • Single pregnancy
  • Expectant mothers with internet access,
  • Expectant mothers who can use digital tools (Smartphone or computer)
  • Mothers with healthy babies
  • Mothers whose babies were born at term (between 37-42 GH)
  • Mothers discharged with their baby
  • Those whose baby is with the mother
  • Expectant mothers who do not attend pregnancy education classes

You may not qualify if:

  • The mother has communication problems,
  • The mother has a chronic illness,
  • Having problems with breastfeeding (breast or newborn),
  • The newborn has IUGR or genetic disease,
  • Failure to attend training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Fatih, Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Bilgic FS, Bozkurt G. The Effect of Online Infant Care Education and Postpartum Counseling Based on Meleis's Transition Theory on Mothers' Self-Esteem and Infant Health: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70045. doi: 10.1111/nhs.70045.

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Gülçin Bozkurt, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 3, 2022

First Posted

April 14, 2023

Study Start

March 30, 2023

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

April 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Research data collection: 6 months Analysis of data: 3 Months Reporting and publication preparation: 3 Months

Locations