NCT05500638: VR-ESMEPP

Effect of VR-ESMEPP on Parents' Seizure Management

Completed NA Last updated 15 August 2022

What this trial tests

NA trial testing Virtual Reality in Virtual Reality in 91 participants. Completed in 7 February 2020.

Timeline

6 August 2018

Primary endpoint
16 August 2019

7 February 2020

Quick facts

Lead sponsor	Akdeniz University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	91
Start date	6 August 2018
Primary completion	16 August 2019
Estimated completion	7 February 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Virtual Reality

Conditions studied

• Virtual Reality — all drugs for Virtual Reality →
• Epilepsy — all drugs for Epilepsy →
• Seizure — all drugs for Seizure →
• Child — all drugs for Child →

Sponsor

Akdeniz University

Who can join

Eligibility, any sex, with Virtual Reality or Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: This study aims to evaluate the knowledge, skills, and motivation of parents regarding management of epileptic seizures, by developing a "Virtual Reality Based Seizure Management Education Program for Parents (VR-ESMEPP).

Method: This study is a double-blinded, pretest-posttest, observational randomized controlled study. The administration stage of the study was conducted between September 2018-February 2020 with parents of 91 children who were diagnosed with epilepsy and were being followed in the Pediatric Neurology Outpatient Department of Akdeniz University Hospital. The parents were distributed into groups with simple randomization (VR Group n=45-Control Group n=46). During the preparation stage of the study, data collection tools "Management-of-Epileptic Seizure-Training-Program-Prepared-with-Virtual-Reality-Technology" and "Patient Scenario Regarding Secondary Generalized Tonic-Clonic Epileptic Scenario with Aura" were prepared and integrated into the virtual reality glasses. In the administration stage, the intervention group was administered the pretest, then the training program, and a posttest immediately following the training. The participants were monitored on the 15th day. For the control group, a pretest, routine outpatient clinical practices, and a posttest were carried out; and the participants were monitored on day 15. In both groups, data were obtained with data collection tools that were integrated into the virtual reality glasses. An approval from the Ethics Committee of Akdeniz University, a written permission from the Akdeniz University Hospital, and informed consent from the parents were obtained to conduct the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.