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

NCT ID: NCT06144450

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-12-01

Brief 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.

Detailed Description

Premature infants' hospital, home transition, and home care needs differ from those of other infants. After being discharged from the neonatal intensive care unit, mothers become the primary caregivers for their premature infants at home. Therefore, discharge preparation should begin when the infant is admitted to the hospital, continue throughout the neonatal intensive care unit stay, and be supported by home follow-up. It has been observed that mothers who have not adequately prepared for discharge often find themselves unprepared for their infants' discharge from the hospital and for providing adequate care at home Nurses provide discharge preparation to facilitate the mother's preparation for discharge, the mother and infant's transition to home, and home care. This preparation can support the mother's stress level and problem-solving skills, as well as the infant's physiological stability and age-appropriate growth and development. Supporting and empowering mothers of premature infants while their infants are in the neonatal intensive care unit is a critical nursing intervention. Therefore, neonatal intensive care unit nurses can use the Family-Centered Empowerment Model to empower mothers. The Family-Centered Empowerment Model has been shown to increase parenting responsibility, care skills, parental self-efficacy, self-, quality of life, and emotional regulation, and to decrease the burden of care in mothers of sick children through integrated programs. The use of technology in healthcare makes information more accessible.

Conditions

Infant Development; Maternal Stress; Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Web-Based Monitoring Program

Intervention Type: OTHER

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.

Control Group

No intervention will be made in the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For mothers

• Those over 18 years of age,
• Literate,
• Having a computer or mobile phone,
• Having access to internet connection,
• Able to use the Internet,
• Able to speak Turkish,
• Primiparous,
• Mothers who agree to participate in the study will be included in the study.
• For babies

• 28-316. born during the week of pregnancy,
• Birth weight 1000-2000 grams. the one which,
• Hospitalized for at least 5 days,
• Prematurity and related health problems (respiratory distress syndrome, intra cranial hemorrhage, patent ductus arteriosus, intrauterine growth retardation, small for gestational age, SEPSIS, retinopathy of prematurity, cholestasis, nutritional intolerance)
• Babies without congenital anomalies will be included in the study.

Exclusion Criteria

• Mothers with physical and/or mental disabilities,
• Mothers diagnosed with a psychological disease (severe depression, suicide attempt, etc.),
• Mothers who are addicted to alcohol and substances,
• Mothers who cannot complete the modules will not be included in the research.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Rukiye Çelik

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rukiye Çelik

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022-439

Identifier Type: -

Identifier Source: org_study_id