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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04343352
Other study ID # DSAYIK
Secondary ID Ayfer ACIKGOZSev
Status Completed
Phase N/A
First received
Last updated
Start date October 17, 2020
Est. completion date January 15, 2022

Study information

Verified date March 2022
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Chronic disease is defined as a condition that deviates from the normal, results from pathological changes and leaves permanent insufficiency, continues for a long time, and requires special training, long-term care and treatment for the patient's rehabilitation. Epilepsy, one of the chronic diseases, is one of the most common neurological disorders in childhood. The main goal in the treatment of epilepsy; It is based on the principle of ensuring seizure without harming the child's growth and development potential. In other words, controlling the seizures is to correctly identify the cause of the seizure and to help the child live a normal life. According to the National Institute for Health and Clinical Excellence, the role of the epilepsy specialist nurse in epilepsy management is not limited to seizure control, but requires multi-dimensional care planning. It is an important nursing role to regulate the lifestyle and increase the compliance with the treatment to increase the patients' non-seizure. At the same time, the key roles of the epilepsy nurse include continuing cooperation with other healthcare team members, collaborating with the public and epilepsy-related organizations, and providing necessary information and educational support to families and children. However, the support given to the family and the child is limited to the times that may come only with controls or for urgent reasons. Detailed solutions will be found to ensure the continuity of this support. Today, with the widespread use of the internet, healthcare education is increasing day by day. Web-based training applications prepared by professional experts are for information such as guidance, information and encouragement for patients with limited time and their parents. Participants phone contains at least one smartphone in almost every home in the internet age. there may be mobile applications to install. With the use of mobile applications in health care services, it is seen that the quality of life of the patients and their relatives and the quality of health care services increase, but also contributes economically to health institutions. The aim of the research is to develop and evaluate the effectiveness of the mobile epilepsy education program for parents with children diagnosed with epilepsy.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
implementation of mobile epilepsy training program
Mobile epilepsy training program will be applied to the application group for 3 months. The mobile epilepsy training program developed within the scope of the thesis will be introduced to the parents in the application group and the participants will be uploaded to their phones via computer, and the use of the program will be taught in practice. In addition, the participants in the application group will be informed that the mobile epilepsy training program is not open to everyone during the research process, only the application group can use it. After the work is completed, the mobile application control group will be installed on the phones of the parents via computer, their application will be taught and applied.

Locations

Country Name City State
Turkey Eskisehir City Hospital Odunpazari Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
DILEK SAYIK

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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 allClick here to view all references

Outcome

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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