Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies

NCT06144450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-08-08

No results posted yet for this study

Summary

The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills. The population of the study will consist of mothers of premature infants receiving care and treatment in the neonatal intensive care units where the study is planned to be conducted between December 15, 2023 and December 01, 2024. Because no similar study was found in the literature, the sample calculation was performed using the G\*power 3.1.9.2 program with effect size = 0.40, type 1 error = 0.05, and 95% power. The analysis yielded a sample size of 52, and considering a 20% loss rate, the total sample size was determined to be 62. Premature infants and their mothers sampled in the study will be assigned to the intervention and control groups by randomization with the stratified block method according to the gestation week, gender and birth weight of the infants. Block randomization will be done by creating 6 blocks consisting of 4 letters. Block randomization will be done by an academic independent of the research. The group with which the study will start will be determined by lottery by the independent academic and the participants will be assigned to the intervention and control groups with randomization envelopes. Mother Descriptive Information Form, Infant Descriptive Information and Follow-up Form, Preparation for Discharge from the Neonatal Intensive Care Unit and Home Care Scale, Neonatal Intensive Care Unit Parental Stress Scale, Problem Solving Skills Assessment Form, Ankara Developmental Screening Inventory, and Process Evaluation Form will be used for data collection. The research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The implementation of the program based on the Empowerment Model will be implemented in 3 stages: preparation of the premature infant hospitalized in the neonatal intensive care unit for discharge from the hospital, transition to home and home care.

Conditions

  • Infant Development
  • Maternal Stress
  • Growth

Interventions

OTHER

Web-Based Monitoring Program

The research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The topics to be included in the monitoring program will be prepared within the framework of the "Empowerment Model". Knowledge and attitude-self-efficacy will be tried to be increased with the modules to be prepared. Accordingly, the program is planned to consist of 3 modules. These are "Preparation for Hospital Discharge Module", "Transitional Care Module" and "Home Care Module". The presented modules will be made accessible to mothers in the experimental group through a website. The modules will be completed in order and the necessary forms and follow-ups will be completed at the end of each module.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Rukiye Çelik · Gazi University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144450 on ClinicalTrials.gov