The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality

NCT06352476 | Active Not Recruiting DMC

• 1 other identifier: 10881-669
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 people's 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 (http://www.psikiyatri.net/uyku-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.

Conditions

Epilepsy

Keywords

Epilectic Seizeures Related to Sleep Deprivation; Epilepsy; Sleep Deprivation; Sleep Hygiene

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  Insomnia complaints of epilepsy patients who experience seizures due to insomnia

  Three months

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index

  Three months

Other Outcomes (1)

• epileptic seizure diary

  Three months

Study Arms (2)

sleep hygiene training

EXPERIMENTAL

Experimental group first interview; Routine treatment of patients will continue. The interview will be face to face, and after obtaining consent from the patients, the Epilepsy Patient Information Form and Pittsburg Sleep Quality Index (PSQI) will be applied. Sleep hygiene training will be provided, and patients will be given a sleep hygiene training booklet and training video. After the training, the Pittsburg Sleep Quality Index (PSQI) will be applied. Patients will be given an Epileptic Seizure Diary and a Sleep Hygiene Chart, and they will be asked and evaluated together at the next meeting. Experimental group second interview; and the third meeting will be held once a month, and sleep hygiene training will be provided through face-to-face meetings with the patients. After the training, the Pittsburg Sleep Quality Index (PSQI) will be applied and the Epileptic Seizure Diary and Sleep hygiene chart will be requested from the patients and evaluated together.

Behavioral: Sleep Hygiene Training

Placebo Comparator

NO INTERVENTION

Routine treatment of the Control/Placebo group will continue. His insomnia and seizures will be monitored for three months. The survey will be filled out during monthly meetings.

Interventions

Sleep Hygiene Training BEHAVIORAL

The effect of sleep hygiene education in a pre-test quasi-experimental study.

sleep hygiene training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with epilepsy for at least one year Volunteer to participate in the research Able to read and write Turkish No communication barriers (psychiatric/hereditary problems, ability to speak and understand Turkish) Able to swallow antiepileptic drugs (Gabapentin, valproic acid, phenytoin, phenobarbital, carbamazepine, levetiracetam, etc.), Having had three or more epileptic seizures in the last year Epilepsies who declare that they have sleep problems and whose Pittsburgh Sleep Quality Index (PSQI) is 5 points or above.

You may not qualify if:

• Want to leave work who underwent surgery during the study alcohol drinkers Benzodiazepine, sedative, etc. those who swallow tablets Those who do not swallow antiepileptic drug tablets deceased

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Smith G, Wagner JL, Edwards JC. CE: Epilepsy Update, Part 1: Refining Our Understanding of a Complex Disease. Am J Nurs. 2015 May;115(5):40-7; quiz 48-9. doi: 10.1097/01.NAJ.0000465030.89975.e8.

  PMID: 25859747 BACKGROUND

Related Links

• It became a guide to the sleep hygiene training booklet

MeSH Terms

Conditions

Epilepsy; Sleep Deprivation; Sleep Hygiene

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know whether he or she is in the experimental or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research is an experimental study with a pre-test and post-test control group trial model.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)