Effect of VR-ESMEPP on Parents' Seizure Management

Akdeniz University

Status: Completed

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

Treatments: Behavioral: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05500638

2012-KAEK-20-730

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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91 participants in 2 patient groups

Virtual Reality Group

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Reality

Control Group

No Intervention group

Description:

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.