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NCT Number: NCT04311151

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

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.

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Key information

Conditions

Epilepsy Behavior Brain Diseases Central Nervous System Diseases Epilepsy; Seizure Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Risk Behavior Risk-Taking Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

own seizures visualization

Procedure

At the hospital discharge, patients

Primary outcomes

  1. change from baseline patient's perception of the severity of his or her own disease

    Time frame: five minutes pre-visualization and five minutes post-visualization of self seizures, and three months later.

    self reported perceived severity of the disease through a visual analog scale (VAS).

  2. change from patient's habits/risk behavior

    Time frame: five minutes pre-visualization and five minutes post -visualization of self seizures, and three months later

    conducted interview through several questions in the VICE questionnaire, related to intention of change risky behavior habits

Secondary outcomes

  1. baseline quality of life

    Time frame: During the hospital admission (pre visualization of self seizures)

    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.

  2. baseline severity of depressive symptoms

    Time frame: During the hospital admission (pre visualization of self seizures)

    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.

  3. anxiety trait and state

    Time frame: five minutes pre-visualization and five minutes post -visualization of self seizures

    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.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Germans Trias i Pujol Hospital

Registry information

Official study title

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

Acronym: VICE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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