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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.
Neonatal seizures are among the most common neurological emergencies occurring within the first 28 days of life and are associated with significant risks for both short- and long-term neurodevelopmental outcomes. After discharge from the neonatal intensive care unit, seizure recurrence and antiepileptic drug management may create substantial uncertainty and anxiety, particularly for families of high-risk infants. Although the medical management of neonatal seizures and the psychological experiences of parents have been examined separately in the literature, there is a lack of comprehensive approaches that combine technology-based risk prediction with targeted educational interventions.
This study aims to identify infants at high risk of seizure recurrence after discharge by using a machine learning model developed from retrospective clinical data and to evaluate the effect of mobile video-supported education provided to mothers of these infants on their knowledge and anxiety levels.
The study is designed as a mixed-methods study and will be conducted in three phases. In the first phase, retrospective clinical data of infants discharged from the neonatal intensive care unit will be used to develop a machine learning-based risk prediction model for seizure recurrence after discharge. In the second phase, qualitative interviews will be conducted with mothers of high-risk infants to determine their educational needs, concerns, and experiences regarding neonatal seizure management. The findings obtained from these interviews will be used to develop the content of the mobile video-supported education program. In the third phase, mothers of high-risk infants will be randomly assigned to intervention and control groups in a randomized controlled experimental design. The intervention group will receive mobile video-supported education in addition to standard discharge education, while the control group will receive standard discharge education only. The effects of the education program on mothers' knowledge and anxiety levels will be evaluated during the follow-up period.
This study is expected to contribute to the early identification of high-risk infants, support the personalization of nursing care, improve parental knowledge regarding seizure management, and reduce anxiety among mothers caring for infants at risk of seizure recurrence after discharge.
Keywords: Neonatal seizure, machine learning, mobile video education, parental anxiety, knowledge level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Mothers in this group will receive standard discharge education only. They will not receive the mobile video-supported education during the intervention period. Their knowledge and anxiety levels will be assessed during the follow-up period. | |
| Mobile Video-Supported Education Group | Experimental | Mothers in this group will receive mobile video-supported education in addition to standard discharge education. The education will focus on neonatal seizure recognition, safety measures, antiseizure medication management, emergency response, and follow-up care. Their knowledge and anxiety levels will be assessed during the follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 week, 1 month, and 3 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kübra Ergün, PhD Student, MSc, RN | Contact | +90 534 819 12 20 | kubraergunn95@gmail.com | |
| Eda AktaÅŸ, Assoc. Prof., PhD | Contact | +90 530 558 90 36 | eda.aktas@sbu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Eda AktaÅŸ | University of Health Sciences Turkey, Hamidiye Faculty of Nursing | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34212365 | Background | Shellhaas RA, Wusthoff CJ, Numis AL, Chu CJ, Massey SL, Abend NS, Soul JS, Chang T, Lemmon ME, Thomas C, McNamara NA, Guillet R, Franck LS, Sturza J, McCulloch CE, Glass HC. Early-life epilepsy after acute symptomatic neonatal seizures: A prospective multicenter study. Epilepsia. 2021 Aug;62(8):1871-1882. doi: 10.1111/epi.16978. Epub 2021 Jul 2. | |
| 34028496 |
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No individual participant data will be shared due to privacy and confidentiality considerations related to maternal and neonatal clinical data.
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Mothers of high-risk infants will be randomly assigned to two parallel groups. The intervention group will receive mobile video-supported education in addition to standard discharge education. The control group will receive standard discharge education only. Outcomes will be assessed during follow-up to evaluate the effect of the education program on maternal knowledge and anxiety levels.
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| Baseline, 1 week, 1 month, and 3 months after discharge |
| Glass HC, Soul JS, Chang T, Wusthoff CJ, Chu CJ, Massey SL, Abend NS, Lemmon M, Thomas C, Numis AL, Guillet R, Sturza J, McNamara NA, Rogers EE, Franck LS, McCulloch CE, Shellhaas RA. Safety of Early Discontinuation of Antiseizure Medication After Acute Symptomatic Neonatal Seizures. JAMA Neurol. 2021 Jul 1;78(7):817-825. doi: 10.1001/jamaneurol.2021.1437. |
| 37655702 | Background | Pressler RM, Abend NS, Auvin S, Boylan G, Brigo F, Cilio MR, De Vries LS, Elia M, Espeche A, Hahn CD, Inder T, Jette N, Kakooza-Mwesige A, Mader S, Mizrahi EM, Moshe SL, Nagarajan L, Noyman I, Nunes ML, Samia P, Shany E, Shellhaas RA, Subota A, Triki CC, Tsuchida T, Vinayan KP, Wilmshurst JM, Yozawitz EG, Hartmann H. Treatment of seizures in the neonate: Guidelines and consensus-based recommendations-Special report from the ILAE Task Force on Neonatal Seizures. Epilepsia. 2023 Oct;64(10):2550-2570. doi: 10.1111/epi.17745. Epub 2023 Sep 1. |