Clinical trial NCT06388577: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents
Official title: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents of Children Diagnosed With Epilepsy on Disease Management: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parents
Epilepsy in Children
Disease Management
Keywords: Epilepsy
Parent education
Children
Disease management
Nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these.

Detailed description: In the study, 76 parents will be randomly assigned to intervention and control groups. Participants in the intervention group (n = 36) will be administered the Epilepsy Education Programme based on Pender's Health Promotion Model by the researcher and will be given the education booklet developed by the researcher in line with the literature. The training topics of the intervention programme are: General information about epilepsy, seizure moment management, management of antiepileptic drug treatments, controlling the factors that may trigger seizures, and recommendations to parents about health promoting and protective behaviours. In the training, learning and teaching techniques such as presentation, video demonstration, question and answer sections, lecture and discussion will be applied. The training will last approximately one hour.

The control group (n=36) will not receive any intervention and will only receive the training booklet used in a thesis study published in the past.

From the parents who will participate in the study: 'Parent and Child Introductory Information Form', 'Form for Evaluating Parents' Level of Knowledge about Epilepsy", "General Self-Efficacy Scale", "Health Promoting and Protective Behaviours Scale' tools and "Form for Evaluating the Number of Hospital Admissions' by using Mersin University Hospital records to evaluate the frequency of hospital admission.

Form for Evaluating Parents' Level of Knowledge about Epilepsy was developed by the researcher in line with the literature since there is no Turkish validity and reliability scale to measure the general knowledge levels of parents with children diagnosed with epilepsy about epilepsy in children. Both intervention and control groups will be pre-tested before the training. Post-tests will be performed immediately after the intervention and at the 3rd month.

Eligibility criteria: Inclusion Criteria:

* Parents between the ages of 18 and 65,
* Parents who provide primary care to the child,
* Parents who signed the Informed Volunteer Consent Form,
* Parents who have a child with a medical diagnosis of epilepsy for at least six months,
* Parents whose children are between the ages of 3 and 6 (if the cut-off limits for the age criterion are; parents of children who are 3 years old as of the beginning of the study and who are less than 7 years old will be included in the sample.) will be included in the study.

Exclusion Criteria:

* Parents under the age of 18,
* Parents over 65 years of age,
* Parents who do not sign the Informed Volunteer Consent Form,
* Parents whose child has had epilepsy for less than six months,
* Parents whose child's age is outside the 3 - 6 age range,
* Parents with learning disabilities,
* Parents who are not literate in Turkish,
* Parents whose children are receiving ketogenic diet treatment,
* Parents whose children have non-neurological chronic diseases will not be included in the study.

Primary outcomes:
measure: Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy
timeFrame: Change from before, immediately after and 3 months after implementation
measure: Self-efficacy evaluated using the General Self-Efficacy Scale
timeFrame: Change from before, immediately after and 3 months after implementation
measure: Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale
timeFrame: Change from before, immediately after and 3 months after implementation
Secondary outcomes:
measure: Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions
timeFrame: Change from after and 3 month implementation
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University
Study officials:
affiliation: Advisor
name: Hacer ÇETİN, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References: