Effect of VR-ESMEPP on Parents' Seizure Management

NCT05500638 | Completed DMC

• 1 other identifier: 2012-KAEK-20-730
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Effects on motivation change

  baseline, pre-intervention

• Effects on motivation change

  immediately after the intervention

• Effects on motivation change

  15 days after the intervention

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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.

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

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.

Interventions

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.

Virtual Reality Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Aysegul ISLER DALGIC

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşegül İşler Dalgıç, Prof.

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: At the end of the study, the data of the participants at T0, T1 and T2 times were recorded and stored by the system. The participants, the researcher and the instructor who made the statistics did not see the results of the research.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: A total of two groups as 1 intervention (virtual reality) and control group (usual care)

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: August 6, 2018
• Primary Completion: August 16, 2019
• Study Completion: February 7, 2020
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)