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IRCT20160618028524N3 IRCT 2018-11-26 Shiraz University of Medical Sciences The impact of family empowerment model on life quality of children with epilepsy in selected centers of Shiraz and Kerman universities of medical sciences, 2018 The impact of family empowerment model on life quality of children with epilepsy in selected centers of Shiraz and Kerman universities of medical sciences, 2018 2018-11-26 anticipated 80 Complete https://irct.ir/trial/34580 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling will be done via permuted block randomization. In doing so, a digit will be randomly selected among random numbers and then, 40 blocks with block size of two will be chosen successively as follows: AB (4-0) and BA (9-5). After that, groups A and B will be allocated to intervention and control groups, respectively. N/A The family empowerment. Intervention 1: Intervention group: The intervention group includes the parents who have children with epilepsy, meet the inclusion criteria, and are willing to participate in the research. In the first session, the parents will be required to complete the QOLCE questionnaire. The family empowerment intervention is carried out through two educational sessions. In the first session, the parents will be trained regarding the process, clinical symptoms, diagnosis, and probable complications of the disease through question and answer and educational pamphlets. The second session will involve face-to-face training during seizure, available treatments, recovery process after treatment, and necessity for long-term follow-ups. The training will be carried out both individually and in groups using educational pamphlets. After a month, the questionnaire will be completed by the parents again. Intervention 2: Control group: After selecting the control group participants, they will be required to complete the QOLCE questionnaire in the first session. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire. After a month, the questionnaire will be completed by the parents again. Yes - There is a plan to make this available What will be shared: A large proportion of the data, including the information related to the main outcome measure, will be shared after the end of the study. When: After the end of the study To whom: Researchers in academic and scientific institutions Conditions: Researchers in academic and scientific institutions can use the present study results for their scientific and research works after gaining permission from the authors. Where to obtain: meshham5@gmail.com zahra.mahdavi@iauk.ac.ir How to obtain: Researchers in academic and scientific institutions can use the present study results for their scientific and research works after gaining permission from the authors. Comments:
public Zahra Mahdavi Khanouki
Valiasr Blvd., Islamic Azad University, Kerman Branch
Kerman Iran (Islamic Republic of) 7635131167 +98 343321004350 zahra.mahdavi@iauk.ac.ir Islamic Azad University scientific Dr.Hamid Nemati
Pediatric Neurology Ward, Namazi Hospital, Namazi Square, Shiraz
Shiraz Iran (Islamic Republic of) 7187649635 +98 71 3647 4298 Nematih@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Parents of children aged 3-7 years with epilepsy who have 6 months of diagnosis and initiation of treatment, and according to the doctor's records and diagnosis, need to go and follow up for at least one year. Acquiring informed consent and willingness to participate in research by parents Having Diploma education to bachelor's degree and enough monthly income Not participating in the same educational program The absence of physical and psychological disruption of daily activities Parents are not personnel and health care providers no limit no limit Both Parents of children hospitalized with febrile of convulsion Lifestyle Lifestyle Intervention group: The intervention group includes the parents who have children with epilepsy, meet the inclusion criteria, and are willing to participate in the research. In the first session, the parents will be required to complete the QOLCE questionnaire. The family empowerment intervention is carried out through two educational sessions. In the first session, the parents will be trained regarding the process, clinical symptoms, diagnosis, and probable complications of the disease through question and answer and educational pamphlets. The second session will involve face-to-face training during seizure, available treatments, recovery process after treatment, and necessity for long-term follow-ups. The training will be carried out both individually and in groups using educational pamphlets. After a month, the questionnaire will be completed by the parents again. Control group: After selecting the control group participants, they will be required to complete the QOLCE questionnaire in the first session. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire. After a month, the questionnaire will be completed by the parents again. The main outcome measures of this study are executing the family empowerment program and enhancing the life quality of children suffering from epilepsy. The data will be collected using the Quality of Life in Children with Epilepsy (QOLCE) questionnaire, which is a specific instrument for assessing such children’s quality of life. This instrument has been derived from Health-Related Quality of Life (HRQoL) questionnaire, which is used to evaluate healthcare and medical interventions in both clinical and social domains. Timepoint: The QOLCE questionnaire will be completed by the two groups in the first session. The intervention group will receive the family empowerment program over two educational sessions. In the first session, the parents will be trained regarding the process, clinical symptoms, diagnosis, and probable complications of the disease through question and answer and educational pamphlets. The second session will involve face-to-face training during seizure, available treatments, recovery process after treatment, and necessity for long-term follow-ups. The training will be carried out both individually and in groups using educational pamphlets. After a month, the questionnaire will be completed by the parents again. Considering ethics, the control group parents will receive the educational pamphlets after completing the questionnaire. Method of measurement: The data will be collected using the QOLCE questionnaire, which is a specific instrument for assessing quality of life in children suffering from epilepsy. This instrument has been derived from HRQoL questionnaire, which is used to evaluate healthcare and medical interventions in both clinical and social domains.Children with seizure disorders are normally faced with an increased risk of behavioral and emotional problems, familial and social decline, and lower quality of life. QOLCE evaluates such children’s quality of life in four dimensions, namely cognitive function (22 items), emotional function (17 items), social function (7 items), and physical function (9 items). The items are responded via a 5-point Likert scale. Accordingly, scores 0, 25, 50, 75, and 100 represent very low, low, average, high, and very high functions, respectively. The reliability of QOLCE was approved by Goodwin et al. in 2015. Shiraz University of Medical Sciences Approved 2018-10-02 Ethic's committee of Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, opposite Felestine St. Zand St. Shiraz, Fars Shiraz Fars Iran (Islamic Republic of)