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Clinical Trial Summary

The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. It is aimed to find a statistically significant difference from the scales (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) at the end of the training of adolescents who received an 8-week training program.


Clinical Trial Description

Research Hypotheses H1: There is a difference between the seizure self-efficacy scale scores of the intervention group based on the IMB model and the control group. H2: There is a difference between perceived social support of scale scores of the intervention group based on the IMB model and the control group. H3: There is a difference between child attitude towards illness scale scores of the intervention group based on the IMB model and the control group. H4: There is a difference between knowledge test for epilepsy disease scale scores of the intervention group based on the IMB model and the control group. Epilepsy is the most common neurological disease in childhood. Due to the diagnosis in childhood, parents take a more active role in disease management, while the child remains more passive in this process. In this period, the burden of adaptation of the parents to the treatment passes to the adolescent who is in the process of transition from childhood to adulthood. The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Adolescents have low personal motivation for disease management and therefore need more social support from parents and peers. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. Fisher et al. developed the IBM model in order to develop health behaviour for HIV prevention in adolescents. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. In the studies conducted, it was determined that the fact that the model was simple, understandable, low cost and clearly defined implementation stages supported adolescents to develop health behaviour skills. When the international and national literature was examined, no training based on the Knowledge Motivation Behaviour model for adolescents with epilepsy was found. The fact that the model is simple, understandable, low cost and clearly defined implementation stages will support the disease management of adolescents. It is thought that adolescents who are well informed and well motivated with the training based on the Knowledge Motivation Behaviour model and who have developed behavioural skills with training can support disease management. IMPLEMENTATION OF RESEARCH Data will be collected in the pediatric neurology department of a university hospital in the Mediterranean region of southern Turkey. Patients and their parents who meet the inclusion criteria will be informed about the study and the education training. Verbal consent will be obtained by the researcher from the patient who agrees to participate in the study. Pre-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) will be applied. After the forms are administered, the assignment sequence, registration of the participants and patients will be assigned to the intervention or control groups by an independent researcher. Written informed consent will then be obtained from patients assigned to the intervention and control groups and their parents. Adolescents with epilepsy in the intervention group will receive an 8-session educational training. Each session will be limited to 10-12 adolescents and the intervention group will be divided into three groups of 11. Each session of the training will be limited to 40-50 minutes. The researchers are working as a lecturer in the departments of pediatric health and diseases nursing and pediatric neurology and as a specialist nurse with a total of 14 years of experience in the neonatal intensive care unit and paediatric health and diseases service. Sessions will be held with the participation of at least one of the researchers. Sessions will be held with the participation of at least one researcher. The training program was developed by researchers and program development specialists. Within the scope of the research, a separate session on seizure management will be held for an individual requested by the adolescents in order to increase the social support level of the adolescents. Post-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Own Illness Scale) were administered to the adolescents in the intervention group immediately after completing the 8-session training program and one month later (twice in total). Towards Attitude Scale) will be applied again. Informed written consent forms will be obtained from the adolescents in the control group and their parents immediately after they accept the research, and pre-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Attitude Towards His Own Illness Scale. ) will be applied. After the pre-test forms are applied, no intervention will be applied to the control group. . Adolescents in the control group will not receive any intervention other than standard care and routine monitoring provided by the doctor and nurse at the outpatient clinic. Immediately after the training program given to the adolescents in the intervention group was completed and one month later (twice in total), post-test forms were administered to the control group (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Self-Efficacy Scale). Attitude Towards Illness Scale) will be administered again. After the data collection phase, after the analysis of the data and determining that the training program is effective, the training program will be applied to the control group without any changes in the training program given to the intervention group. STATISTICAL A statistical package program will be used in the analysis of the data. The conformity of the mean scores of the scale to the normal distribution will be evaluated with the coefficients of kurtosis and skewness, and the means will be compared with parametric or nonparametric test techniques. The similarity of the groups in terms of demographic and clinical characteristics will be evaluated with the relevant tests. Cohen's d effect size will be calculated to express the size of the difference between the means. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06045520
Study type Interventional
Source Mersin University
Contact OZLEM GUZEL POLAT, 1
Phone +905067685660
Email ozlemgzl@mersin.edu.tr
Status Recruiting
Phase N/A
Start date November 15, 2023
Completion date August 30, 2024

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