Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior

Study Overview
=================
Brief Summary
-----------------
In Spain, an estimated 690,000 persons have epilepsy, of whom 270,000 have active epilepsy (defined as those who have had a seizure in the last 5 years). It is estimated that 30% of patients diagnosed with epilepsy are drug-resistant. Patients with loss of consciousness or impaired awareness during seizures are at higher risk of injury due to accidents. To prevent such injuries, it is important that patients are sufficiently knowledgeable about their disease to allow them to avoid risk behavior. In this project, we want to know if visualization of self seizures has an impact on the perception of the severity of the disease, as well as on the risky behavior habits.

Detailed Description
-----------------
Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care. Main aims: To determine whether self-visualization of seizures in patients with epilepsy modifies risk perception compared with patients not viewing their own seizures. To determine whether viewing their seizures leads patients with epilepsy to plan changes in their risk behavior compared with patients not viewing their own seizures. Design: Quasi-experimental study with a control group. Intervention group: standard of care and self-visualization of epileptic seizures. Control group: standard of care. Sample size: Accepting an alpha risk of 0.05 and a beta risk lower than 0.2 on bilateral comparison, 50 participants will be needed in the intervention group and 25 in the control group to detect statistically significant differences between the proportion of patients showing behavioral change. It is expected that behavioral change will occur in 40% of the intervention group and 10% of the control group and that losses to follow-up will be 10%. Variables: Sociodemographic, risk perception, intention to change behavior, perception of disease severity, quality of life, mood/depression, personality traits, anxiety. Data collection: pre and post visualization of self seizures, and three months after discharge. A descriptive analysis will be performed, with percentages and frequencies for qualitative variables and mean ± standard deviation (or median [range] depending on the normality of the distribution) for quantitative variables. Inferential analysis will be conducted with the chi-square test or nonparametric tests depending on the behavior of the variables obtained. This project has been approved by the Clinical Research Ethics Committee of the hospital performing the study.

Official Title
-----------------
Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior (VICE)

Conditions
-----------------
Epilepsy, Epilepsy; Seizure, Risk Behavior, Risk-Taking

Intervention / Treatment
-----------------
* Procedure: own seizures visualization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for the control group: patients aged 18 years or older admitted to the Epilepsy Unit of Hospital del Mar who voluntarily accept to participate in the study after prior psychological assessment. for the control group: patients admitted to the Epilepsy Unit of Hospital Germans Tries who voluntarily accept to participate in the study. Exclusion Criteria: Patients with no risk behavior according to the ad hoc questionnaire administered on admission. Cognitive impairment preventing adequate comprehension of the study. Vision-impaired patients and those with language barriers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self seizures visualization group<br>Visualization of the own epileptic seizures occured during hospital admission. | Procedure: own seizures visualization<br>* At the hospital discharge, patients<br>|
| No Intervention: usual management<br>Usual way management | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline patient's perception of the severity of his or her own disease | self reported perceived severity of the disease through a visual analog scale (VAS). | five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later. | 
| change from patient's habits/risk behavior | conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits | five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline quality of life | measure of the quality of life specifically in patients with epilepsy, through the Quality of Life in Epilepsy Inventory-10(QUOLIE-10), validated spanish version. This inventory ranges from 10 to 50. The higher the score, the worse quality of life. | During the hospital admission (pre visualization of self seizures) | 
| baseline severity of depressive symptoms | self reported severity of depressive symptoms through the Beck Depression Inventory Second Edition (BDI-II), validated spanish version. This inventory ranges from 0 to 63. The higher the score, the highest severity of depressive symptoms. | During the hospital admission (pre visualization of self seizures) | 
| anxiety trait and state | self reported anxiety trait and state through the State-Trait Anxiety Inventory-STAI, validated spanish version. Scores range from 20 to 80, with higher scores correlating with greater anxiety. This is a two part questionnaire. The state part will be reported five minutes pre and post visualization of self seizures, while the trait part will be reported only five minutes pre visualization. | five minutes pre-visualization and five minutes post -visualization of self seizures | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, Risk-Taking, risk behavior, seizure, visualization