ParentsNCT06388577
The Effect of the Training Programme Based on the Health Promotion Model Given to Parents
A study testing Education in people with Parents and Epilepsy in Children, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parents, Epilepsy in Children, Disease Management
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 13 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkey, Mersin University
Mersin
Sümerya YASTI, MASTER, 2204160171012@mersin.edu.tr
Hacer ÇETİN, PROFESSOR
About this study
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
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.
Read the 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.
- Conditions
- Parents, Epilepsy in Children, Disease Management
- Being tested
- Education
- Keywords
- Epilepsy, Parent education, Children, Disease management, Nursing
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | 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. Receives: Other: Education |
| Control | No intervention | No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy
Since there was no Turkish validity-reliability scale to measure parents' knowledge levels about epilepsy in children, the form was developed by the researcher in line with the literature.
The form consists of 4 sub-dimensions and a total of 24 items: epilepsy disease, seizure management, medication management, and knowledge levels regarding controlling factors that may trigger seizures.
The form is a measurement tool with two options, in which parents mark the appropriate option between 'true' and 'false'. The opinions of five experts were taken to evaluate the content validity of the form. As a result of expert evaluations, the content validity rate of each item in the survey and the content validity index of each sub-dimension were calculated separately. The result was found to be statistically significant and it was decided to use the survey in the research. The analysis of the results will be evaluated by taking the opinion of a statistician.
Measured: Change from before, immediately after and 3 months after implementation
Self-efficacy evaluated using the General Self-Efficacy Scale
The validity and reliability study of the Turkish form of the General Self-Efficacy Scale was conducted by Aypay (2010). In Aypay's (2010) study, the construct validity of the scale was evaluated by factor analysis. There are no reverse coded items in the scale. The Cronbach alpha coefficient value of the scale is 0.83. The scale, which has a 4-point Likert structure consisting of ten items, asks the participant to answer each item as "Completely False", "Somewhat True", "Moderately True" and "Completely True" and is obtained by selecting the most appropriate one of these items. The lowest score that can be obtained from the scale is 10 and the highest score is 40. The increase in the total score the participants received from the scale means that their general self-efficacy levels increased. As a result of the research, it was accepted that the Turkish version of the scale is a valid and reliable data collection tool.
Measured: Change from before, immediately after and 3 months after implementation
Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale
The scale was developed by Bostan (2016). It consists of three subscales and a total of 24 items. It is a 5-point Likert type. The total Cronbach α coefficient value of the scale was found to be 0.83. Cronbach's α coefficient values for the sub-dimensions are; physical 0.62, psychosocial 0.61 and protection 0.76. The construct validity of the scale was performed by confirmatory factor analysis. It was observed that the obtained evaluation results did not exceed the theoretical limits of the fit parameters. The minimum score that can be obtained from the scale is 24 and the maximum score is 120. Items 1, 3, 4, 5, 12, 13, 14, and 23 of the scale are reverse coded. Analyzes can be made separately as sub-dimensions and total score. The low total score of the participants is considered as a sign that they do not demonstrate health-promoting and protective behaviors. According to the study data, the scale was accepted to be a valid and reliable measurement tool.
Measured: Change from before, immediately after and 3 months after implementation
Secondary outcomes (1)
Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions
Data will be collected using a form using Mersin University Hospital records. The number of times parents applied to the hospital for their children within the 3-month period after the training will be evaluated and recorded in this form.
Measured: Change from after and 3 month implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start13 May 2024 (estimated)
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümerya YASTI, Mersin University
- Investigators
- Hacer ÇETİN, PROFESSOR, Principal investigator, Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388577
- Sponsor's protocol ID
- MEU-HEM-SY-189
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06388577
- Acronym / sponsor ID
- MEU-HEM-SY-189
- Conditions
- Parents, Epilepsy in Children, Disease Management
- Keywords
- Epilepsy, Parent education, Children, Disease management, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (estimated)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Sep 2024 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: EducationParticipants 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. |
| Control | No intervention | –No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationParticipants 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. | Other | Education |
Primary outcome
Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy
Time frame: Change from before, immediately after and 3 months after implementation
Since there was no Turkish validity-reliability scale to measure parents' knowledge levels about epilepsy in children, the form was developed by the researcher in line with the literature. The form consists of 4 sub-dimensions and a total of 24 items: epilepsy disease, seizure management, medication management, and knowledge levels regarding controlling factors that may trigger seizures. The form is a measurement tool with two options, in which parents mark the appropriate option between 'true' and 'false'. The opinions of five experts were taken to evaluate the content validity of the form. As a result of expert evaluations, the content validity rate of each item in the survey and the content validity index of each sub-dimension were calculated separately. The result was found to be statistically significant and it was decided to use the survey in the research. The analysis of the results will be evaluated by taking the opinion of a statistician.
Self-efficacy evaluated using the General Self-Efficacy Scale
Time frame: Change from before, immediately after and 3 months after implementation
The validity and reliability study of the Turkish form of the General Self-Efficacy Scale was conducted by Aypay (2010). In Aypay's (2010) study, the construct validity of the scale was evaluated by factor analysis. There are no reverse coded items in the scale. The Cronbach alpha coefficient value of the scale is 0.83. The scale, which has a 4-point Likert structure consisting of ten items, asks the participant to answer each item as "Completely False", "Somewhat True", "Moderately True" and "Completely True" and is obtained by selecting the most appropriate one of these items. The lowest score that can be obtained from the scale is 10 and the highest score is 40. The increase in the total score the participants received from the scale means that their general self-efficacy levels increased. As a result of the research, it was accepted that the Turkish version of the scale is a valid and reliable data collection tool.
Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale
Time frame: Change from before, immediately after and 3 months after implementation
The scale was developed by Bostan (2016). It consists of three subscales and a total of 24 items. It is a 5-point Likert type. The total Cronbach α coefficient value of the scale was found to be 0.83. Cronbach's α coefficient values for the sub-dimensions are; physical 0.62, psychosocial 0.61 and protection 0.76. The construct validity of the scale was performed by confirmatory factor analysis. It was observed that the obtained evaluation results did not exceed the theoretical limits of the fit parameters. The minimum score that can be obtained from the scale is 24 and the maximum score is 120. Items 1, 3, 4, 5, 12, 13, 14, and 23 of the scale are reverse coded. Analyzes can be made separately as sub-dimensions and total score. The low total score of the participants is considered as a sign that they do not demonstrate health-promoting and protective behaviors. According to the study data, the scale was accepted to be a valid and reliable measurement tool.
1 secondary outcome
Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions
Time frame: Change from after and 3 month implementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Parents
Active, not recruiting
Pediatric Parenting Support in Flint
Healthy, Family Research
Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Factors Associated With a Child's Development of Interaction and Communication Skills and Measures Taken, Reported Stress Level of the Parents of a Newborn and Measures Taken
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hacer ÇETİN, PROFESSOR principal investigator
Advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Parents and Epilepsy in Children, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sümerya YASTI, MASTER (+90 324 241 00 00 ext. 22405, 2204160171012@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy (time frame: Change from before, immediately after and 3 months after implementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.