Mobile Video Education and Machine Learning-Based Risk Prediction in Neonatal Seizure Management

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstanbul Saglik Bilimleri University

About this trial

This mixed-methods study will develop a machine learning-based model to identify infants at high risk of seizure recurrence after discharge from the neonatal intensive care unit. Based on qualitative interviews with mothers, a mobile video-supported education program will be developed. In the randomized controlled phase, mothers of high-risk infants will be assigned to intervention and control groups to evaluate the effect of the education on knowledge and anxiety levels during follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The infant is classified as high risk according to the machine learning-based risk prediction model developed in the first phase of the study.

The infant is planned to be discharged home from the Neonatal Intensive Care Unit of Başakşehir Çam and Sakura City Hospital.

The mother is 18 years of age or older.

The mother is the primary caregiver responsible for the infant's care.

Disqualifiers

The infant is transferred to another center before completion of the study process or during the discharge period.

The infant dies during the study period.

The mother has a diagnosed cognitive or psychiatric condition that may prevent her from understanding the educational materials or managing the study process.

The mother has a visual or hearing impairment that may prevent her from following the video content.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobile Video-Supported Education

    Behavioral

    The mobile video-supported education program will be provided to mothers of high-risk infants in addition to standard discharge education. The program will include video-based educational content on neonatal seizure recognition, safety precautions, antiseizure medication management, emergency response, and follow-up care after discharge. The education content will be developed based on qualitative interviews with mothers and will aim to improve maternal knowledge and reduce anxiety related to neonatal seizure management.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Mobile Video-Supported Education GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Maternal Knowledge Level Regarding Neonatal Seizure Management

Maternal knowledge regarding neonatal seizure management will be assessed using a structured knowledge form developed for the study. The form will evaluate mothers' knowledge about seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Higher scores indicate a higher level of knowledge.

Time frame
Baseline, 1 week, 1 month, and 3 months after discharge

Secondary outcomes

1

Change in Maternal Anxiety Level Assessed by the State-Trait Anxiety Inventory (STAI)

Maternal anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The scale consists of two subscales: State Anxiety and Trait Anxiety, each including 20 items. Scores range from 20 to 80 for each subscale, with higher scores indicating higher anxiety levels. Changes in anxiety scores between the intervention and control groups will be evaluated during follow-up.

Time frame
Baseline, 1 week, 1 month, and 3 months after discharge

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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