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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06144450
• Other study ID #: 2022-439
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 November 15, 2023 and June 01, 2024. Since there is no similar study in the literature, the sample size of the study will be determined as a result of the post-hoc power analysis performed after the pre-application in all groups. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• For mothers

• Those over 18 years of age,

• Literate,

• Having a computer or smartphone,

• 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.

Related Conditions & MeSH terms

• Growth
• Infant Development
• Maternal Stress
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baby Monitoring Form	Growth-development parameters of birth, discharge and home care (Height - meters)	at birth, 1st month, 3rd month
Primary	Neonatal Intensive Care Unit Parental Stress Scale	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
Primary	Neonatal Intensive Care Unit Parental Stress Scale	Scale; The sub-dimensions are Babies' Appearance and Behavior, Sights and Sounds, Your Relationship with Your Baby, and Your Role as a Parent.Items with a mean score between 3.0 and 3.40 are considered moderately stressful, and items with a mean score >3.40 are considered very stressful. The lowest score is 1, the highest score is 5.	at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Primary	Problem Solving Skills Evaluation Form	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
Primary	Preparation for Discharge from Neonatal Intensive Care Unit and Home Care Scale	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
Primary	Process Evaluation Form	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
Primary	Ankara Developmental Screening Inventory	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
Primary	Baby Monitoring Form	receiving emergency healthcare services after discharge (rate)	at birth, 1st month, 3rd month
Primary	Baby Monitoring Form	Growth-development parameters of birth, discharge and home care (weight in kilograms)	at birth, 1st month, 3rd month