Effect of VR-ESMEPP on Parents' Seizure Management

NCT ID: NCT05500638

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2020-02-07

Brief Summary

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.

Detailed Description

Objective: Parents of children with epilepsy need support when managing epileptic seizures outside medical-care-center-settings. Previously developed training programs only provide information-based support. Therefore, within the scope of the VR-ESMEPP, a conceptual framework was developed in this study with the aim of developing parents' skills and motivation as well as providing them information regarding seizure management.

Methods: The conceptual framework of the VR-ESMEPP was developed in four steps. In step 1, a scenario was developed wherein an epileptic pediatric patient is having a seizure. The selected seizure type was generalized-tonic-clonic-seizure, which is the most common and most skill-intensive type of tonic-clonic-seizure. In step 2, data collection tools related to epileptic seizure management were developed for parents. These tools included Child and Parent Introductory Form, Parental Information Assessment Form for Epileptic Seizure Management, and Parental Skills Assessment Form for Epileptic Seizure Management. In step 3, the conceptual framework and data collection tools developed were confirmed by a group of 10 specialists consisting of physicians and pediatric nurses working in the field of pediatric neurology. In step 4, the epileptic-pediatric-patient-scenario and data collection tools confirmed by experts were programmed into an application by a software company and integrated into virtual reality headsets.

Conditions

Virtual Reality; Epilepsy; Seizure; Child; Nurse; Parents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Virtual Reality Group

Firstly, the intervention group was administered the pretest, then the training program (VR-ESMEPP), and a posttest immediately following the training. The participants were monitored on the 15th day.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

At this stage, trainings were given for epileptic seizures. Parents were asked to wear SG glasses and they were trained on the correct approach to seizures over the Focal to bilateral tonic-clonic seizure scenario integrated into the SG glasses. The clinic and process of focal to bilateral tonic-clonic seizure and the training of what to do and not to do during the seizure were given again through SG glasses. Parents interfered with the patient scenario many times during their free work time and had the chance to interfere with the seizure again and again by restarting the seizure.

Control Group

For the control group, a pretest, routine outpatient clinical practices, and a posttest were carried out; and the participants were monitored on day 15. They took usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

At this stage, trainings were given for epileptic seizures. Parents were asked to wear SG glasses and they were trained on the correct approach to seizures over the Focal to bilateral tonic-clonic seizure scenario integrated into the SG glasses. The clinic and process of focal to bilateral tonic-clonic seizure and the training of what to do and not to do during the seizure were given again through SG glasses. Parents interfered with the patient scenario many times during their free work time and had the chance to interfere with the seizure again and again by restarting the seizure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Parents who had a child with a diagnosis of "focal to bilateral tonic-clonic" seizure, who could speak Turkish, who had no limitations in hearing, vision and hand motor skills in order to use the virtual reality glasses effectively, were included in the study.

Exclusion Criteria

• Participants outside of these criteria were excluded from the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Ayşegül İşler Dalgıç

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşegül İşler Dalgıç, Prof.

Role: STUDY_DIRECTOR

Akdeniz University

Locations

Aysegul ISLER DALGIC

Antalya, Konyaaltı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2012-KAEK-20-730

Identifier Type: -

Identifier Source: org_study_id