Epilepsy Clinical Trial
Official title:
Randomized Controlled Study: Evaluation of the Efficiency of Mobile Application for Parents of Children With Epilepsy
Verified date | March 2022 |
Source | Eskisehir Osmangazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: support to family and child related to epilepsy, controls or when they come for urgent reasons. Solutions must be found to ensure its continuity. this support. The widespread use of the Internet today, e-health and health education is increasing day by day. Objective: The investigators research is planned to develop a mobile Epilepsy Training Program. Parents with children diagnosed with epilepsy and assessing its effectiveness. Material and Method: The research is a randomized controlled experimental study. An application was made to the Eskişehir Osmangazi University Clinical Research Ethics Committee and the ethics committee permission was obtained with the decision of 13.02.2020 dated 80558721-050.99-E.20230 and 2019-66 decision. Only volunteer participants will be included in the research. Its population study 3-6 years old children diagnosed with epilepsy Eskişehir City Hospital Child Neurology Outpatient Clinic between 01 September 2020 and 31 September 2021. The sample of the research will consist of parents who meet the inclusion criteria. research between these dates. Parents meeting research sample selection criteria The application was randomized as a control group according to the Parent Epilepsy Information Scale. Application group; will use the mobile application the investigators prepared for the parent. Control group will consist of parents who follow the hospital's treatment protocol. The investigators study Completed with a total of 60 parents, 30 of whom are determined by power analysis group. Statistical analysis will be done with SPSS package program. Keywords: Child, Epilepsy, Parent Education, Mobile Application, Child Nurse
Status | Completed |
Enrollment | 60 |
Est. completion date | January 15, 2022 |
Est. primary completion date | January 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Can use and use Android based smart phone, - Literate, - Volunteers to participate in the study, - Does not have any other chronic disease other than epilepsy, - Parents with a child aged 3-6 years who are diagnosed with epilepsy at least six months ago (Tutar Güven, 2018) will be included in the study. Exclusion Criteria: - without an Android-based smartphone, - IOS phone, - Not capable of using mobile applications, - Mentally disabled child - Hearing impaired and do not speak Turkish - Parents who are not willing to participate in the study will not be included in the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Eskisehir City Hospital | Odunpazari | Eskisehir |
Lead Sponsor | Collaborator |
---|---|
DILEK SAYIK |
Turkey,
Çavusoglu, H. Çocuk sagligi hemsireligi, 10. Baski. Ankara: Sistem Ofset Basimevi. 2011; 330-348.
Dennis TA, O'Toole L. Mental Health on the Go: Effects of a Gamified Attention Bias Modification Mobile Application in Trait Anxious Adults. Clin Psychol Sci. 2014 Sep 1;2(5):576-590. — View Citation
Falco-Walter JJ, Scheffer IE, Fisher RS. The new definition and classification of seizures and epilepsy. Epilepsy Res. 2018 Jan;139:73-79. doi: 10.1016/j.eplepsyres.2017.11.015. Epub 2017 Nov 28. Review. — View Citation
Fazlioglu, K., Hocaoglu, Ç., & Sönmez F. M. Çocukluk Çagi Epilepsisinin Aileye Etkisi. Psikiyatride Güncel Yaklasimlar, 2010; 2(2):189-205.
Mo PK, Coulson NS. Developing a model for online support group use, empowering processes and psychosocial outcomes for individuals living with HIV/AIDS. Psychol Health. 2012;27(4):445-59. doi: 10.1080/08870446.2011.592981. Epub 2011 Aug 19. — View Citation
National Institue for Health and Clinical Excellence. (2004). The diagnosis and management of the epilepsis in adults and children in primary and secondary care, NICE. Available from: http://www.nice.org.uk/nicemedia/pdf/CG020NICEguideline.pdf Access Date: 01.07.2019.
O'Conner-Von S. Coping with cancer: a Web-based educational program for early and middle adolescents. J Pediatr Oncol Nurs. 2009 Jul-Aug;26(4):230-41. doi: 10.1177/1043454209334417. Epub 2009 May 15. — View Citation
Rodenburg R, Marie Meijer A, Dekovic M, Aldenkamp AP. Family predictors of psychopathology in children with epilepsy. Epilepsia. 2006 Mar;47(3):601-14. — View Citation
Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshé SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8. — View Citation
Tutar Güven, S. Ergen ve ebeveynlerine yönelik gelistirilen web tabanli epilepsi egitim programinin etkinliginin degerlendirilmesi, Doktora Tezi, Akdeniz Üniversitesi Saglik Bilimleri Enstitüsü, Antalya. 2018
Wohlrab GC, Rinnert S, Bettendorf U, Fischbach H, Heinen G, Klein P, Kluger G, Jacob K, Rahn D, Winter R, Pfäfflin M; Famoses Project Group. famoses: a modular educational program for children with epilepsy and their parents. Epilepsy Behav. 2007 Feb;10(1):44-8. Epub 2006 Nov 27. — View Citation
Zararsiz, M. (2009). Epilepside güvenligin saglanmasina iliskin çocuga ve ebeveynlere verilen egitimin etkinliginin degerlendirilmesi, Yüksek Lisans Tezi, Mersin Üniversitesi Saglik Bilimleri Enstitüsü, Mersin
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the knowledge of the applicant group about epilepsy disease | Change in the knowledge of the application group about epilepsy disease assessed with the Parent Epilepsy Information Scale "Parent Epilepsy Information Scale" will be filled in before and after the study (after 3 months) with the researcher, in order to measure the level of knowledge of parents about epilepsy.
The high total score indicates that families have a high level of knowledge. Parents in the application group are expected to have an increased knowledge of epilepsy. |
12 weeks | |
Primary | Change in anxiety of the applicant group about epilepsy disease | Change in anxiety level about epilepsy disease assessed with the The Parental Anxiety Scale for Seizures "The Parental Anxiety Scale for Seizures" will be filled with the face-to-face interview technique before and after the study (after 3 months) to determine the anxiety of the families of children with seizures. It is interpreted as the parental anxiety decreases as the score obtained from the scale increases.
Anxiety levels of parents in the application group are expected to decrease. |
12 weeks |
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