Effect of VR-ESMEPP on Parents' Seizure Management

Epilepsy Clinical Trial

— VR-ESMEPP  

Official title:

Effect of Virtual Reality Based Seizure Management Education Program for Parents (VR-ESMEPP) on Seizure Management: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500638
• Other study ID #: 2012-KAEK-20-730
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: February 7, 2020

Study information

• Verified date: August 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 7, 2020
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Epilepsy
• Nurse
• Parents
• Seizure
• Seizures
• Virtual Reality

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Aysegul ISLER DALGIC	Antalya	Konyaalti

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on knowledge about epilepsy change	Parental Information Assessment Form for Epileptic Seizure Management. This form was prepared by researchers in line with the relevant literature to evaluate the parents' level of knowledge related to seizure intervention. The form consists of a total of 22 binary Likert-type questions answered as "True" or "False." Four questions included reverse statements.	baseline, pre-intervention
Primary	Effects on knowledge about epilepsy change	Parental Information Assessment Form for Epileptic Seizure Management. This form was prepared by researchers in line with the relevant literature to evaluate the parents' level of knowledge related to seizure intervention. The form consists of a total of 22 binary Likert-type questions answered as "True" or "False." Four questions included reverse statements.	immediately after the intervention
Primary	Effects on knowledge about epilepsy change	Parental Information Assessment Form for Epileptic Seizure Management. This form was prepared by researchers in line with the relevant literature to evaluate the parents' level of knowledge related to seizure intervention. The form consists of a total of 22 binary Likert-type questions answered as "True" or "False." Four questions included reverse statements.	15 days after the intervention
Primary	Effects on skill about epileptic seizure time	Parental Skills Assessment Form for Epileptic Seizure Management. This form consists of seven questions prepared by researchers in line with the relevant literature in order to evaluate the seizure intervention-related skills of parents. These seven questions focus on the seven skills that parents are expected to have to perform a seizure intervention. These skills include assessing the child's consciousness when the seizure begins, recording seizure time, removing close objects that may cause injury, loosening the child's clothes, turning the head sideways, and calling for emergency help (calling an ambulance). The expert opinions were obtained regarding the pediatric-patient-scenario and data collection tools developed by the researchers.	baseline, pre-intervention
Primary	Effects on skill about epileptic seizure time	Parental Skills Assessment Form for Epileptic Seizure Management. This form consists of seven questions prepared by researchers in line with the relevant literature in order to evaluate the seizure intervention-related skills of parents. These seven questions focus on the seven skills that parents are expected to have to perform a seizure intervention. These skills include assessing the child's consciousness when the seizure begins, recording seizure time, removing close objects that may cause injury, loosening the child's clothes, turning the head sideways, and calling for emergency help (calling an ambulance). The expert opinions were obtained regarding the pediatric-patient-scenario and data collection tools developed by the researchers.	immediately after the intervention
Primary	Effects on skill about epileptic seizure time	Parental Skills Assessment Form for Epileptic Seizure Management. This form consists of seven questions prepared by researchers in line with the relevant literature in order to evaluate the seizure intervention-related skills of parents. These seven questions focus on the seven skills that parents are expected to have to perform a seizure intervention. These skills include assessing the child's consciousness when the seizure begins, recording seizure time, removing close objects that may cause injury, loosening the child's clothes, turning the head sideways, and calling for emergency help (calling an ambulance).	15 days after the intervention
Secondary	Effects on motivation change	Instructional Materials Motivation Survey. for analog and digital learning environments. 5-point Likert Scale (1 (or A) = Not true; 2 (or B) = Slightly true; 3 (or C) = Moderately true; 4 (or D) = Mostly true; 5 (or E) = Very true). Attention: Cronbachs a: .83 Relevance: Cronbachs a: .81 Satisfaction: Cronbachs a: .92 Confidence: Cronbachs a: . 90	baseline, pre-intervention
Secondary	Effects on motivation change	Instructional Materials Motivation Survey. for analog and digital learning environments. 5-point Likert Scale (1 (or A) = Not true; 2 (or B) = Slightly true; 3 (or C) = Moderately true; 4 (or D) = Mostly true; 5 (or E) = Very true). Attention: Cronbachs a: .83 Relevance: Cronbachs a: .81 Satisfaction: Cronbachs a: .92 Confidence: Cronbachs a: . 90	immediately after the intervention
Secondary	Effects on motivation change	Instructional Materials Motivation Survey. for analog and digital learning environments. 5-point Likert Scale (1 (or A) = Not true; 2 (or B) = Slightly true; 3 (or C) = Moderately true; 4. (or D) = Mostly true; 5 (or E) = Very true). Attention: Cronbachs a: .83 Relevance: Cronbachs a: .81 Satisfaction: Cronbachs a: .92 Confidence: Cronbachs a: . 90	15 days after the intervention