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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06412692
Other study ID # IzmirKCU-GECTAN-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 18, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change.


Description:

Adolescence period; It is an important stage of development in which the self-concept develops, self-related schemas are created and carried into adulthood. During this formative period of life; Adolescents experience increasing levels of uncertainty and self-consciousness as they progress through the task of identity formation. It is greatly influenced by social interactions, especially interactions with peers.Children and adolescents with epilepsy are at increased risk for social problems, reduced social competence, poor social skills, and deficits in social communication compared to healthy children. Compared to youth with other chronic diseases, youth with epilepsy have higher rates of comorbid neurological disorders, academic failure, poor social skills, stigma, poor quality of life, and behavioral health problems (e.g., anxiety, depression). They often experience low quality of life because they feel unsafe and fear having a seizure in public. In a study aiming to investigate the factors affecting the level of social anxiety in epilepsy, it was concluded that social anxiety is independently associated with low quality of life. In a meta-analysis study; It was concluded that the motivational interviewing method applied by nurses increased the quality of life of individuals with chronic diseases. When the literature was examined, no study was found that addressed the motivational interviewing technique applied to the social anxiety and quality of life of adolescents with epilepsy. Motivational Interviewing Technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life by enabling adolescents to become aware of their situation, get rid of the ambivalent (opposite emotional state) they experience, and take action to change.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 72
Est. completion date December 31, 2024
Est. primary completion date May 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 15 Years
Eligibility Inclusion Criteria: - Be between the ages of 12-15 - Having epilepsy for at least six months - Having a high score on the Social Anxiety Scale for Adolescents - Having a low score on the General Child Life Quality Scale - Low scores on the KINDL Epilepsy Quality of Life Module for Children - No mental disability - Able to communicate (can speak and understand Turkish, has no speech disorder) - Being literate - Not having any other chronic disease - Being willing to participate in the study Exclusion Criteria: -Not attending at least one of the interviewing

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The Motivational Interviewing Technique
Motivational interviewing technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life of adolesce.

Locations

Country Name City State
Turkey IzmirKCU Izmir Çigli

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Aburahma SK, Hammouri H, Hazaimeh E, Jbarah O, Nassar A, Almasri A, Al Momani M, Bashtawi M. Social impairment in children with epilepsy assessed by the social responsiveness scale. Clin Child Psychol Psychiatry. 2021 Oct;26(4):1170-1181. doi: 10.1177/13591045211033176. Epub 2021 Jul 16. — View Citation

Clifford LM, Brothers SL, Lang A. Self-Disclosure Patterns Among Children and Youth with Epilepsy: Impact of Perceived-Stigma. Adolesc Health Med Ther. 2023 Feb 5;14:27-43. doi: 10.2147/AHMT.S336124. eCollection 2023. — View Citation

Hosseini N, Mokhtari S, Momeni E, Vossoughi M, Barekatian M. Effect of motivational interviewing on quality of life in patients with epilepsy. Epilepsy Behav. 2016 Feb;55:70-4. doi: 10.1016/j.yebeh.2015.10.012. Epub 2016 Jan 12. — View Citation

Lu Y, Zhong R, Li M, Zhao Q, Zhang X, Hu B, Lin W. Social anxiety is associated with poor quality of life in adults with epilepsy in Northeast China: A cross-sectional study. Epilepsy Behav. 2021 Apr;117:107866. doi: 10.1016/j.yebeh.2021.107866. Epub 2021 Mar 5. — View Citation

Tolchin B, Baslet G, Martino S, Suzuki J, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Motivational Interviewing Techniques to Improve Psychotherapy Adherence and Outcomes for Patients With Psychogenic Nonepileptic Seizures. J Neuropsychiatry Clin Neurosci. 2020 Spring;32(2):125-131. doi: 10.1176/appi.neuropsych.19020045. Epub 2019 Aug 30. — View Citation

Tolchin B, Baslet G, Suzuki J, Martino S, Blumenfeld H, Hirsch LJ, Altalib H, Dworetzky BA. Randomized controlled trial of motivational interviewing for psychogenic nonepileptic seizures. Epilepsia. 2019 May;60(5):986-995. doi: 10.1111/epi.14728. Epub 2019 Apr 13. — View Citation

Uzun S, Ozmaya E. The effect of motivational interview conducted by nurses on quality of life: Meta-analysis. Perspect Psychiatr Care. 2022 Oct;58(4):2449-2459. doi: 10.1111/ppc.13080. Epub 2022 Apr 5. — View Citation

Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary "Social Anxiety Scale for Adolescents" [Time Frame: After the motivational interviewing technique] A high score on the Social Anxiety Scale for Adolescents indicates high anxiety. 3 months
Primary ''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: After the motivational interviewing technique] A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life. 3 months
Primary "Children's General Quality of Life Scale'' [Time Frame: After the motivational interviewing technique] A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life. 3 months
Primary "Social Anxiety Scale for Adolescents" [Time Frame: 1 month after the Motivational Interviewing Technique] A high score on the Social Anxiety Scale for Adolescents indicates high anxiety. 1 months
Primary ''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: 1 month after the Motivational Interviewing Technique] A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life. 1 months
Primary "Children's General Quality of Life Scale" [Time Frame: 1 month after the Motivational Interviewing Technique] A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life. 1 months
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