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Completed

NCT Number: NCT05500638

Effect of VR-ESMEPP on Parents' Seizure Management

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.

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Key information

Conditions

Virtual Reality Brain Diseases Central Nervous System Diseases Child Epilepsy Nervous System Diseases Neurologic Manifestations Nurse Parents Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aysegul ISLER DALGIC

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

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.

Primary outcomes

  1. Effects on knowledge about epilepsy change

    Time frame: baseline, pre-intervention

    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.

  2. Effects on knowledge about epilepsy change

    Time frame: immediately after the intervention

    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.

  3. Effects on knowledge about epilepsy change

    Time frame: 15 days after the intervention

    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.

  4. Effects on skill about epileptic seizure time

    Time frame: baseline, pre-intervention

    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.

  5. Effects on skill about epileptic seizure time

    Time frame: immediately after the intervention

    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.

  6. Effects on skill about epileptic seizure time

    Time frame: 15 days after the intervention

    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).

Secondary outcomes

  1. Effects on motivation change

    Time frame: baseline, pre-intervention

    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 α: .83 Relevance: Cronbachs α: .81 Satisfaction: Cronbachs α: .92 Confidence: Cronbachs α: . 90

  2. Effects on motivation change

    Time frame: immediately after the intervention

    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 α: .83 Relevance: Cronbachs α: .81 Satisfaction: Cronbachs α: .92 Confidence: Cronbachs α: . 90

  3. Effects on motivation change

    Time frame: 15 days after the intervention

    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 α: .83 Relevance: Cronbachs α: .81 Satisfaction: Cronbachs α: .92 Confidence: Cronbachs α: . 90

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Acronym: VR-ESMEPP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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