Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352476
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-24
Brief Title:
The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Sleep Hygiene Training on Seizure Frequency and Sleep Quality in Epilepsy Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Epilepsy is a disease that can be seen in everyone including neurological chronic elderly and children An estimated 50 million people in the world have epilepsy patients have a history of two or more seizures the exact cause is unknown it negatively affects home work and school life and it directs individuals from their independent roles to semi-dependent and fully dependent roles Smith Wagner Jonathan 2015 Neuronal networks hypersynchronization develops epileptic seizures can cause insomnia and sleep quality may decrease with drug treatment Sünter and Ağan 2019 NREM sleep causes seizures through the ictal and interactive effect of sleep Alp and Altındağ 2014 Insomnia increases seizure discharges neurological and systemic complications may develop and serious morbidity and mortality may occur Özer 2005 Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia Gümüşyayla and Vural 2017 Complementary medical approaches are also recommended along with drug treatment Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases With good sleep health symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges Gammino at all 2016 Quality sleep is essential for physiological and psychological health and sleep disorders can be corrected with sleep hygiene training Günaş 2018 Randomized studies including sleep hygiene training are needed to prevent seizure recurrences prevent or treat comorbid psychological diseases and improve life activities of epilepsy patients Lee at all 2015 One-third of peoples lives are spent in sleep regular and adequate sleep protects physiological and psychological health sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases sleep hygiene training is cost-free and easy to implement where daily activities and behaviors are regulated appropriate environmental conditions are provided By regulating the circadian rhythm melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release httpwwwpsikiyatrinetuyku-hijyeni Access date 28 May 2022 Alp and Altındağ 2014 Güneş 2018 No research has been found on sleep hygiene training to relieve sleep deprivation which is common in epilepsy patients With good sleep hygiene sleep and quality of life can be improved and epileptic seizures can be prevented or reduced
Purpose of the research To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model
Purpose of the research To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model
Detailed Description:
Epilepsy is a non-communicable disease and is included in chronic diseases it can be seen in all age groups WHO 2022 httpswwwwhointennews-roomfact-sheetsdetailepilepsy Access date28 May 2022 Epilepsy patients were under intense stress during the coronavirus epidemic experienced intense anxiety and sleep disorders and their quality of life was negatively affected Elmalı et al 2020 In their routine lives epilepsy patients should be compliant with treatment for epilepsy seizure control provide adequate sleep hygiene have a balanced diet and prefer a stress-free life Adadıoğlu and Oğuz 2016 Epilepsy patients complain of excessive daytime sleepiness between 169 and 28 more than 50 experience insomnia at night due to night seizures and accompanying anxiety and depression diseases insomnia triggers epileptiform discharges seizures in 25 of generalized epilepsy patients Studies report that in 97 of epilepsy patients insomnia stress and fatigue worsen the frequency and pattern of seizures When sleep hygiene is ensured It inhibits the release of stress hormones such as cortisol and noradrenaline from the hypothalamic pituitary and provides epileptic seizure control Nunes at all 2020 With sleep hygiene training it improves sleep quality and quality of life in chronic diseases and sleep disorders Muz et al 2021 Ekinci 2020 Nurses play an important role in the management of epilepsy and in supporting patients and their relatives individuals are negatively affected psychologically and socially especially seizure control and preventing possible complications protection from trauma during seizures and providing emergency intervention detection of self-care deficiencies compliance with medication treatment emotional changes preventing fatigue and weakness correct exercise avoiding stress preventing eating disorders They contribute greatly to the quality of life with their educational and consultant roles in correcting sleep disorders and preventing sleep disorders Enç et al 2017 Ovayolu and Ovayolu 2017 Özer 2005
Our goals Our aim is to improve sleep quality and control seizures with the sleep hygiene training we provide to epilepsy patients
Research Questions
1 How does the sleep hygiene training given to patients with epilepsy in the experimental group affect their sleep quality
2 Is there a relationship between sociodemographic characteristics and insomnia in patients with epilepsy in the experimental group
3 Is there a significant difference between the experimental group and the control group Patients diagnosed with epilepsy who applied to the neurology outpatient clinic of the hospital where the research is planned to be conducted constitute the population of the study The number of samples was determined by power analysis and the experimental and control groups will be determined by randomization Sleep hygiene training will be given to the experimental group and before and after surveys will be filled out The control group will not be trained We aim to contribute to scientific knowledge with this study
Non-drug clinical research pre-test post-test control group trial model experimentally planned research data After obtaining written consent from the patients in a face-to-face interview by the researcher between 01 June 2023 and 01 December 2024 the experimental group was given an epilepsy patient introduction form and PSQI Pittsburg Sleep Quality Index and sleep hygiene training will be given to the patient and a sleep hygiene booklet and training video will be given to the patient A meeting with the patient is planned for one month later The patients seizure frequency will be evaluated with the seizure schedule and sleep quality will be evaluated with the Pittsburg sleep quality index and sleep hygiene education will be given to the patient again A follow-up meeting will be scheduled one month after the second interview and seizure frequency and sleep quality will be re-evaluated with the forms The research will be completed with the third interview with the experimental group Three interviews will be held with the control group After obtaining written consent from the patient to participate in the research the epilepsy patient introduction form and PSQI Pittsburgh Sleep Quality Index are filled in and a meeting with the patient is planned for one month later The patients seizure frequency will be evaluated with the seizure chart and sleep quality will be evaluated with the Pittsburg sleep quality index The third interview will be planned one month after the second interview and the patients seizure frequency and sleep quality will be evaluated with the seizure schedule and the Pittsburg sleep quality index will be evaluated Afterwards the sleep hygiene booklet will be given to the patient and the study will be terminated
In order for the research findings to represent the population of the study the sample of the study was determined to be a total of 50 with 25 patients each with 80 power for the experimentalcontrol groups using power analysis with α005 and β03 Considering the patient participants situations such as death and withdrawal from the study and in order for the study to be parametric it was determined that a total of 160 patients would be reached 80 patients each in the experimental and control groups Data analysis of the research will be carried out by performing the necessary statistical operations in a computer environment and evaluating the results at a 95 confidence interval and a significance level of p 005 If the data shows a normal distribution parametric tests Student t test Anova will be used If the data does not show a normal distribution nonparametric tests Wilcoxon Kruskal -Wallis H Test and Test-retest analyzes will be used
Our goals Our aim is to improve sleep quality and control seizures with the sleep hygiene training we provide to epilepsy patients
Research Questions
1 How does the sleep hygiene training given to patients with epilepsy in the experimental group affect their sleep quality
2 Is there a relationship between sociodemographic characteristics and insomnia in patients with epilepsy in the experimental group
3 Is there a significant difference between the experimental group and the control group Patients diagnosed with epilepsy who applied to the neurology outpatient clinic of the hospital where the research is planned to be conducted constitute the population of the study The number of samples was determined by power analysis and the experimental and control groups will be determined by randomization Sleep hygiene training will be given to the experimental group and before and after surveys will be filled out The control group will not be trained We aim to contribute to scientific knowledge with this study
Non-drug clinical research pre-test post-test control group trial model experimentally planned research data After obtaining written consent from the patients in a face-to-face interview by the researcher between 01 June 2023 and 01 December 2024 the experimental group was given an epilepsy patient introduction form and PSQI Pittsburg Sleep Quality Index and sleep hygiene training will be given to the patient and a sleep hygiene booklet and training video will be given to the patient A meeting with the patient is planned for one month later The patients seizure frequency will be evaluated with the seizure schedule and sleep quality will be evaluated with the Pittsburg sleep quality index and sleep hygiene education will be given to the patient again A follow-up meeting will be scheduled one month after the second interview and seizure frequency and sleep quality will be re-evaluated with the forms The research will be completed with the third interview with the experimental group Three interviews will be held with the control group After obtaining written consent from the patient to participate in the research the epilepsy patient introduction form and PSQI Pittsburgh Sleep Quality Index are filled in and a meeting with the patient is planned for one month later The patients seizure frequency will be evaluated with the seizure chart and sleep quality will be evaluated with the Pittsburg sleep quality index The third interview will be planned one month after the second interview and the patients seizure frequency and sleep quality will be evaluated with the seizure schedule and the Pittsburg sleep quality index will be evaluated Afterwards the sleep hygiene booklet will be given to the patient and the study will be terminated
In order for the research findings to represent the population of the study the sample of the study was determined to be a total of 50 with 25 patients each with 80 power for the experimentalcontrol groups using power analysis with α005 and β03 Considering the patient participants situations such as death and withdrawal from the study and in order for the study to be parametric it was determined that a total of 160 patients would be reached 80 patients each in the experimental and control groups Data analysis of the research will be carried out by performing the necessary statistical operations in a computer environment and evaluating the results at a 95 confidence interval and a significance level of p 005 If the data shows a normal distribution parametric tests Student t test Anova will be used If the data does not show a normal distribution nonparametric tests Wilcoxon Kruskal -Wallis H Test and Test-retest analyzes will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None