Clinical trial NCT05500638: Effect of VR-ESMEPP on Parents' Seizure Management
Official title: Effect of Virtual Reality Based Seizure Management Education Program for Parents (VR-ESMEPP) on Seizure Management: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Epilepsy
Seizure
Child
Nurse
Parents
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of two groups as 1 intervention (virtual reality) and control group (usual care)
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Effects on knowledge about epilepsy change
timeFrame: baseline, pre-intervention
measure: Effects on knowledge about epilepsy change
timeFrame: immediately after the intervention
measure: Effects on knowledge about epilepsy change
timeFrame: 15 days after the intervention
measure: Effects on skill about epileptic seizure time
timeFrame: baseline, pre-intervention
measure: Effects on skill about epileptic seizure time
timeFrame: immediately after the intervention
measure: Effects on skill about epileptic seizure time
timeFrame: 15 days after the intervention
Secondary outcomes:
measure: Effects on motivation change
timeFrame: baseline, pre-intervention
measure: Effects on motivation change
timeFrame: immediately after the intervention
measure: Effects on motivation change
timeFrame: 15 days after the intervention
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Aysegul ISLER DALGIC
state: Konyaaltı
Study officials:
affiliation: Akdeniz University
name: Ayşegül İşler Dalgıç, Prof.
role: STUDY_DIRECTOR
References: