The Individual and Family Self Management Theory Based Epilepsy Education Program's Effectiveness

NCT ID: NCT04822662

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2022-03-11

Brief Summary

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The aim of the study; to determine the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

Detailed Description

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In addition to the expected effects of epilepsy on children, the course of the disease and the course of the child's life will change as the duration of life with the disease increases. In epilepsy, it is necessary to develop self-management behaviors in order to facilitate adaptation to the disease, to encourage seizure control and to increase the quality of life. Regular repetition of the trainings created within the framework of a certain plan to improve self-management behaviors is one of the recommended steps to strengthen the individual with chronic disease in the disease process. This randomized controlled study including aged 12-18 adolescents with a diagnosis of epilepsy, monotherapy, mental retardation without cerebral palsy, and no secondary disease and their parents. However, there isn't enough published research examining the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

Conditions

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Self Management Epilepsy; Seizure Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, stratified sampling was employed based on age and sex. Two strata, \[12-14 age, girl\] and \[15-18 age, boy\], were generated to ensure even distribution in terms of age and sex in each group. First, thirty-six adolescent were stratified into two groups (A and B), which were then stratified again into two: \[12-14 age, girl\] and \[15-18 age, boy\]. A scheme was developed to randomize the age and sex of \[12-14, girl\] and \[15-18 age, boy\] into two groups (A and B), resulting in the experimental and control groups stratified by the age and sex and blocked into paired-groups of (2:2/\[12-14 age, girl\]:\[15-18 age, boy\]). Permutation was also used to strike a balance between the strata. Block sets were generated for each combination of the prognostic factors (age and sex). The experimental and control groups were then randomized into the strata using a random numbers table.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single Blinded (Participant, Outcomes Assessor)

Study Groups

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Experimental Group: Epilepsy education program

The training prepared for epilepsy will be held in 3 main modules and 5 sessions with two weeks intervals. Each session will last 25 minutes. Trainings will be given to adolescents and their parents online.

Group Type EXPERIMENTAL

Epilepsy Education Programme

Intervention Type BEHAVIORAL

Firstly the Child Introduction Form and Parent Information Form were applied. Then the Child's Attitude Towards Self-Disease Scale, Seizure Self-Efficacy Scale for Children, Quality of Life Scale for Children were filled to children. Nurse-Parent Support Scale were applied to the parents in the Pretest and Post Test data.

Control Group

The control group will receive standard epilepsy treatment without any training intervention. The group did not receive any other intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epilepsy Education Programme

Firstly the Child Introduction Form and Parent Information Form were applied. Then the Child's Attitude Towards Self-Disease Scale, Seizure Self-Efficacy Scale for Children, Quality of Life Scale for Children were filled to children. Nurse-Parent Support Scale were applied to the parents in the Pretest and Post Test data.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Having a diagnosis of epilepsy for at least 6 months,
* Being in the age range of 12-18 years,
* Cerebral palsy, attention deficit, lack of mental retardation, except for a different physical or epilepsy,
* Receiving monotherapy treatment for epilepsy
* To be able to communicate in Turkish

Exclusion Criteria

* Cerebral palsy, attention deficit, mental retardation other than epilepsy,
* Patients who are over the age of 18 or who switch to an adult care program,
* Not being open to communication and cooperation, not taking polytherapy
* Adolescents not continuing the monitoring phase or wanting to stop working at any stage,
* Prior history of seizures due to screen exposure
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

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Hilal Kurt

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilal Kurt Sezer, Master

Role: PRINCIPAL_INVESTIGATOR

KTO Karatay University

Sibel KUCUKOGLU, Assoch prof

Role: STUDY_DIRECTOR

Selcuk University

Abdullah Canbal, Dr

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

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Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Austin JK, Huberty TJ. Development of the Child Attitude Toward Illness Scale. J Pediatr Psychol. 1993 Aug;18(4):467-80. doi: 10.1093/jpepsy/18.4.467.

Reference Type RESULT
PMID: 8410570 (View on PubMed)

Tutar Guven S, Isler A. Validity and Reliability of the Seizure Self-Efficacy Scale for Children with Epilepsy. Noro Psikiyatr Ars. 2015 Mar;52(1):47-53. doi: 10.5152/npa.2015.7399. Epub 2015 Mar 1.

Reference Type RESULT
PMID: 28360675 (View on PubMed)

Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

Reference Type RESULT
PMID: 11468499 (View on PubMed)

Miles MS, Carlson J, Brunssen S. The nurse parent support tool. J Pediatr Nurs. 1999 Feb;14(1):44-50. doi: 10.1016/S0882-5963(99)80059-1.

Reference Type RESULT
PMID: 10063248 (View on PubMed)

Caplin D, Austin JK, Dunn DW, Shen J, Perkins S. Development of a self-efficacy scale for children and adolescents with epilepsy. Children's Health Care. 2002; 31(4): 295-309.

Reference Type RESULT

Ersun A, Bolışık B. VALIDITY AND RELIABILITY OF THE TURKISH ADAPTATION OF THE CHILD ATTITUDE TOWARD ILLNESS SCALE. EGEHFD. 2012; 28:37-45.

Reference Type RESULT

Sezer HK, Kucukoglu S, Canbal A. The effectiveness of an individual and family self-management theory-based education program given for adolescents with epilepsy and parents: Randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:171-180. doi: 10.1016/j.pedn.2024.08.026. Epub 2024 Sep 13.

Reference Type DERIVED
PMID: 39276443 (View on PubMed)

Other Identifiers

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KaratayUh01

Identifier Type: -

Identifier Source: org_study_id

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