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Effect of VR-ESMEPP on Parents' Seizure Management (VR-ESMEPP)

Primary Purpose

Virtual Reality, Epilepsy, Seizure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virtual Reality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Aysegul ISLER DALGIC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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).

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2022
Last Updated
August 11, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05500638
Brief Title
Effect of VR-ESMEPP on Parents' Seizure Management
Acronym
VR-ESMEPP
Official Title
Effect of Virtual Reality Based Seizure Management Education Program for Parents (VR-ESMEPP) on Seizure Management: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Epilepsy, Seizure, Child, Nurse, Parents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of two groups as 1 intervention (virtual reality) and control group (usual care)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
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 Outcome Measure Information:
Title
Effects on knowledge about epilepsy change
Description
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.
Time Frame
baseline, pre-intervention
Title
Effects on knowledge about epilepsy change
Description
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.
Time Frame
immediately after the intervention
Title
Effects on knowledge about epilepsy change
Description
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.
Time Frame
15 days after the intervention
Title
Effects on skill about epileptic seizure time
Description
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.
Time Frame
baseline, pre-intervention
Title
Effects on skill about epileptic seizure time
Description
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.
Time Frame
immediately after the intervention
Title
Effects on skill about epileptic seizure time
Description
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).
Time Frame
15 days after the intervention
Secondary Outcome Measure Information:
Title
Effects on motivation change
Description
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
Time Frame
baseline, pre-intervention
Title
Effects on motivation change
Description
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
Time Frame
immediately after the intervention
Title
Effects on motivation change
Description
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
Time Frame
15 days after the intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşegül İşler Dalgıç, Prof.
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Aysegul ISLER DALGIC
City
Antalya
State/Province
Konyaaltı
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of VR-ESMEPP on Parents' Seizure Management

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