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

August 7, 2025 updated by: Rukiye Çelik, Gazi University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06360
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Control Group
No intervention will be made in the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Problem Solving Skills Evaluation Form
Time Frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Subscales of the form are Child (Baby) Care Skill Subscale, Scanning Subscale, Formulation Subscale, Pre-evaluation (Prediction) Subscale, Planning Subscale, Application Subscale, Evaluation Subscale, Problem Solving Process Subscale.The lowest score that can be obtained from the entire scale is 27 and the highest score is 261.As the score increases, mothers' problem-solving skills increase.
at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Preparation for Discharge from Neonatal Intensive Care Unit and Home Care Scale
Time Frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
The scale developed for mothers includes 4 sub-dimensions (feeding, general condition perception, hygienic care, care practices). A minimum of 22 and a maximum of 154 points can be obtained from the mother scale. High scores indicate that parents are ready for discharge.
at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Process Evaluation Form
Time Frame: through discharge, an average of 3 month
9 open-ended questions are asked about the benefits of the program, satisfaction levels with the program, the effects of the program on the feeling of knowledge and competence in baby care, the conveniences and difficulties of the program, and suggestions for the program.This form is a form in which qualitative and quantitative data are collected. Therefore, it has no upper and lower scores.
through discharge, an average of 3 month
Ankara Developmental Screening Inventory
Time Frame: through discharge, an average of 1 month; through discharge, an average of 3 month
It is a screening inventory that provides in-depth and systematic information about the development of babies and children (0 -6 years old).The inventory consists of 4 subdomains: language-cognitive, fine motor, gross motor and social skills-self-care.
through discharge, an average of 1 month; through discharge, an average of 3 month
Baby Monitoring Form -1
Time Frame: at birth, 1st month, 3rd month
Growth-development parameters of birth, discharge and home care (Height - meters)
at birth, 1st month, 3rd month
Neonatal Intensive Care Unit Parental Stress Scale
Time Frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month. (Increase and decrease over time will be evaluated.)
Scale; The sub-dimensions are Babies' Appearance and Behavior, Sights and Sounds, Your Relationship with Your Baby, and Your Role as a Parent.
at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month. (Increase and decrease over time will be evaluated.)
Baby Monitoring Form -2
Time Frame: at birth, 1st month, 3rd month
receiving emergency healthcare services after discharge (rate)
at birth, 1st month, 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rukiye Çelik, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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