Clinical trial NCT06144450: Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
Official title: Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Development
Maternal Stress
Growth
Keywords: premature infant
mother
discharge
transition to home
home care
nurse
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 62
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baby Monitoring Form -1
timeFrame: at birth, 1st month, 3rd month
measure: Neonatal Intensive Care Unit Parental Stress Scale
timeFrame: 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.)
measure: Problem Solving Skills Evaluation Form
timeFrame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
measure: Preparation for Discharge from Neonatal Intensive Care Unit and Home Care Scale
timeFrame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
measure: Process Evaluation Form
timeFrame: through discharge, an average of 3 month
measure: Ankara Developmental Screening Inventory
timeFrame: through discharge, an average of 1 month; through discharge, an average of 3 month
measure: Baby Monitoring Form -2
timeFrame: at birth, 1st month, 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Rukiye Çelik
role: PRINCIPAL_INVESTIGATOR
References: