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

Quality of Life Clinical Trial

Official title:

The Effectiveness of The Education Program Based on The Individual and Family Self Management Theory Given For Epilepsy Adolescents and Parents: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822662
• Other study ID #: KaratayUh01
• Status: Completed
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2022
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 11, 2022
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy; Seizure
• Quality of Life
• Seizures
• Self Management

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Konya	Meram

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Austin JK, Huberty TJ. Development of the Child Attitude Toward Illness Scale. J Pediatr Psychol. 1993 Aug;18(4):467-80. — View Citation

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.

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

Miles MS, Carlson J, Brunssen S. The nurse parent support tool. J Pediatr Nurs. 1999 Feb;14(1):44-50. — View Citation

Tutar Güven 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Introduction Form	The form consists of 15 questions that question the content dimension (risk factors specific to the disease, factors specific to the physical and social environment, individual and familial factors) and the process dimension concepts (disease-specific knowledge and beliefs, self-regulation, social facilitation).	First measurement - Before education programme (1st week)
Primary	Development of the Child Attitude Toward Illness Scale	Child Attitude Toward Illness Scale was developed by Austin (1993) to measure the attitudes of children with chronic diseases towards their disease. The validity and reliability of the 13-item single-dimension scale was conducted by Ersun and Bolisik (2012) with children aged 9-17 years with epilepsy.; The average score that can be obtained from the scale varies between 1 and 5. The average score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, 4 and 5 indicate positive attitude.	First measurement - Before education programme (1st week)
Primary	Seizure Self-Efficacy Scale for Children	Seizure Self-efficacy Scale for Children was developed by Caplin et al. (2002) and adapted to Turkish by Tutar Güven and Isler Dalgiç (Tutar Güven and Isler 2015). It was conducted with children aged 9-18 years with epilepsy and the Cronbach's alpha value of the scale was 0.89. The scale consists of a single dimension with a 15-item five-point Likert structure and the scale items are scored between 1-5. indicates that it is.	First measurement - Before education programme (1st week)
Primary	The Children's Quality of Life Scale	The Children's Quality of Life Scale was developed in 2001 by Varni et al. For adolescents aged 13-18. The internal consistency coefficient of the scale varies between 0.80-0.88. The Turkish validity and reliability study of the scale was conducted by Çakin Memik et al. In 2007 and the internal consistency coefficient was found to be 0.82. PedsQL, which is one of the general quality of life scales, is a quality of life scale suitable for use in both healthy and ill adolescents. It is a five-point Likert-type scale consisting of 23 items that determines the health-related quality of life of adolescents aged 13-18.	First measurement - Before education programme (1st week)
Primary	Parents Information Form	This form was prepared by the researchers in line with the literature. In the form, the individual and self management theory consists of 15 questions regarding the concepts of content and process dimension.	First measurement - Before education programme (1st week)
Primary	Nurse-Parent Support Scale	The Nurse Parent Support Scale, developed by Miles et al. (1999) and tested by Yigit et al in 2017, consists of 21 items in a five-point likert structure. There is no reverse item in the scale that measures perceived nurse support by parents. The scale consists of four sub-dimensions. The scale consists of four sub-dimensions. These; It consists of 21 items in total: "Information and Communication Support", "Emotional Support", "Respect Support", "Quality Care".	First measurement - Before education programme (1st week)
Secondary	Development of the Child Attitude Toward Illness Scale	Development of the Child Attitude Toward Illness Scale was developed by Austin (1993) to measure the attitudes of children with chronic diseases towards their disease. The validity and reliability of the 13-item single-dimension scale was conducted by Ersun and Bolisik (2012) with children aged 9-17 years with epilepsy.; The average score that can be obtained from the scale varies between 1 and 5. The average score of 1 and 2 indicates negative attitude, 3 indicates neutral attitude, 4 and 5 indicate positive attitude.	Second measurement - After education programme (10th week)
Secondary	Seizure Self-Efficacy Scale for Children	Seizure Self-efficacy Scale for Children was developed by Caplin et al. (2002) and adapted to Turkish by Tutar Güven and Isler Dalgiç (Tutar Güven and Isler 2015). It was conducted with children aged 9-18 years with epilepsy and the Cronbach's alpha value of the scale was 0.89. The scale consists of a single dimension with a 15-item five-point Likert structure and the scale items are scored between 1-5. indicates that it is.	Second measurement - After education programme (10th week)
Secondary	The Children's Quality of Life Scale	The Children's Quality of Life Scale was developed in 2001 by Varni et al. For adolescents aged 13-18. The internal consistency coefficient of the scale varies between 0.80-0.88. The Turkish validity and reliability study of the scale was conducted by Çakin Memik et al. In 2007 and the internal consistency coefficient was found to be 0.82. PedsQL, which is one of the general quality of life scales, is a quality of life scale suitable for use in both healthy and ill adolescents. It is a five-point Likert-type scale consisting of 23 items that determines the health-related quality of life of adolescents aged 13-18.	Second measurement - After education programme (10th week)
Secondary	Nurse-Parent Support Scale	The Nurse Parent Support Scale, developed by Miles et al. (1999) and tested by Yigit et al in 2017, consists of 21 items in a five-point likert structure. There is no reverse item in the scale that measures perceived nurse support by parents. The scale consists of four sub-dimensions. The scale consists of four sub-dimensions. These; It consists of 21 items in total: "Information and Communication Support", "Emotional Support", "Respect Support", "Quality Care".	Second measurement - After education programme (10th week)