NCT06954922

Brief Summary

Epilepsy; It is a chronic, neurological disease that can occur regardless of social class, race and age. Every year, approximately 5 million people worldwide are diagnosed with epilepsy and 50 million people are affected by this disease, constituting a significant part of the disease burden in the world. When we look at the rate of patients in the population who actively experience symptoms of the disease and need treatment, this rate is approximately 4 to 10 people per 1000 people. According to estimates, 700,000 people in Turkey are actively diagnosed with epilepsy. It is accepted that this disease occurs as a result of sudden, abnormal discharge of neurons in some parts of the central nervous system, and the disease generally progresses with recurrent changes in consciousness. The symptoms accompanying epilepsy are perceived negatively by patients and significantly affect their lives. Epilepsy treatment; It consists of several options such as medical drugs, ketogenic diet and surgical intervention. The ultimate goal of treatment is to achieve seizure control, reduce the frequency of seizures, minimize drug side effects that may occur due to long-term treatment, and improve the patient's quality of life. Along with pharmacological treatment, non-pharmacological treatment is also a valuable approach in the treatment of epilepsy. One of the non-pharmacological approaches is rehabilitation interventions with mind and memory exercises. Epilepsy is a disease that requires a complex psychological adaptation for the patient and affects the whole family. In this disease, it is very important for the patient to comply with the treatment requirements, to have self-control over his/her behavior, as well as to cope with the difficulties of living with epilepsy. Increasing the quality of life and preventing possible behavioral problems is possible by keeping mental functions at an optimal level on the one hand, and providing psychological counseling to the patient and his family on the other. Nowadays, epileptic seizures are often more easily controlled with developing pharmacological treatment options. Therefore, the fight against epilepsy should be expanded to include other educational, mental, psychotherapeutic and behavioral interventions besides drug therapy. In a study conducted by the National Center for Health and Care Research (NIHR), electrical activity scans in the brain of 25 epilepsy patients were examined. Some images in different categories were presented to epilepsy patients for a certain period of time. Later, when asked to remember the images shown in the previous step, it was noted that slow waves occurred in the brain during sleep. As a result of the research, it was revealed that the effect of epileptic spikes on brain activity decreased with the emergence of slow waves. This study has demonstrated for the first time a potential protective mechanism used by the brain to counteract epileptic activity. Patients diagnosed with epilepsy who are admitted to the neurology outpatient clinic or admitted to the neurology clinic will be introduced and informed about the study. Patients who want to participate in the study and meet the inclusion criteria will be determined. After patient consent is obtained, groups will be determined according to the randomization list. The patient introduction form and the Quality of Life in Epilepsy Scale will be administered to the patients in both groups by the researcher using the face-to-face interview technique (pre-test). Patients in the experimental group will be informed about memory-based exercise and planned training. Patients in the control group will only be informed about the planned training to be given. The experimental group will be given memory-based exercises that will last approximately 15-20 minutes every day for 2 months. Four sessions of epilepsy training will be given, one session per week. The control group will receive 4 sessions of epilepsy training, one session per week. At the end of two months, the Quality of Life in Epilepsy Scale (posttest) will be applied to both groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 10, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

quality of lifeepilepsyeducation of patiensmemory

Outcome Measures

Primary Outcomes (2)

  • Patient Introduction Form

    It was prepared by the researcher by examining the literature. It consists of 26 questions, including questions such as age, gender, marital status, educational status, family type, social security, income status, epilepsy diagnosis period, frequency of seizures, presence of another disease, constantly used medication.

    2 month

  • Quality of Life Scale in Epilepsy

    QOLIE-31 was developed by Vickrey et al. in 1993. Mollaoğlu and his colleagues were the researchers who conducted the validity and reliability studies of this scale in Turkey in 2015. QOLIE-31; It consists of a total of 31 questions and 7 subcomponents: 5 on the seizure-related concerns sub-dimension, 3 on the effects of medications sub-dimension, 4 on the energy/fatigue sub-dimension, 5 on the emotional well-being sub-dimension, 6 on the cognitive function sub-dimension, 5 on the social function sub-dimension, 2 on the total quality of life sub-dimension and an additional question assessing the total health status. Scale scoring ranges from 0-100 points. A high score indicates a high quality of life. The total Cronbach's Alpha value in the original scale was determined to be 0.91. In this study, the total Cronbach Alpha value of the scale was found to be 0.90.

    2 month

Study Arms (2)

memory-based exercise and training group

EXPERIMENTAL
Behavioral: memory-based exercise and training intervention

training group

EXPERIMENTAL
Behavioral: educational initiative about epilepsy

Interventions

The experimental group will be given memory-based exercises that will last approximately 15-20 minutes every day for 2 months. Four sessions of epilepsy training will be given, one session per week.

memory-based exercise and training group

This group will be given 4 sessions of epilepsy training, one session per week.

training group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being literate,
  • Being over the age of 18,
  • Having sufficient communication skills to answer oral and written questions and follow instructions,
  • Being at a cognitive level to be able to use a mobile phone and perform the memory exercise.
  • Not having severe vision problems,
  • Having been diagnosed with epilepsy for at least 6 months

You may not qualify if:

  • Being under 18 years of age
  • Residing outside Bilecik Province
  • Having psychiatric diagnoses such as Bipolar Disorder and Schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 10, 2025

First Posted

May 2, 2025

Study Start

May 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 2, 2025

Record last verified: 2025-04