Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2025-12-17 @ 4:31 AM
Study NCT ID:
NCT06132854
Status:
None
Last Update Posted:
2025-05-15 00:00:00
First Post:
2023-11-06 00:00:00
Brief Title:
VR Based Simulation in the Preparation of Children for MRI - MRVR
Sponsor:
Semmelweis University
Organization:
Semmelweis University
Study Overview
Official Title:
Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)
Status:
None
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRVR
Brief Summary:
Study Description:
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations. We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations, or if anesthesia is needed less doses of anesthetics are required.
Objectives:
Primary Objective:
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations.
Secondary Objectives:
To evaluate whether fear, mood, anxiety, familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention.
Endpoints:
Primary Endpoint:
The need for any anesthetic or sedative medication during MRI examination.
Secondary Endpoints:
Visual analogue scales related to fear, mood and familiarity, willingness to take part in an MRI examination again.
Study Population: 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled.
Description of Sites/Facilities Enrolling Participants:
The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University
Description of Study Intervention/Experimental Manipulation:
Our research will be conducted as a three arm randomized controlled trial (VR, booklet, usual care). Participants in the VR condition are immersed in a unique 360° VR experience specifically designed for this study.
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination.
In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods.
Study Duration:
36 months
Participant Duration:
All participants need a single visit intervention to complete all study related tasks.
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations. We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations, or if anesthesia is needed less doses of anesthetics are required.
Objectives:
Primary Objective:
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations.
Secondary Objectives:
To evaluate whether fear, mood, anxiety, familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention.
Endpoints:
Primary Endpoint:
The need for any anesthetic or sedative medication during MRI examination.
Secondary Endpoints:
Visual analogue scales related to fear, mood and familiarity, willingness to take part in an MRI examination again.
Study Population: 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled.
Description of Sites/Facilities Enrolling Participants:
The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University
Description of Study Intervention/Experimental Manipulation:
Our research will be conducted as a three arm randomized controlled trial (VR, booklet, usual care). Participants in the VR condition are immersed in a unique 360° VR experience specifically designed for this study.
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination.
In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods.
Study Duration:
36 months
Participant Duration:
All participants need a single visit intervention to complete all study related tasks.
Detailed Description:
Study Description
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations or if anesthesia is needed less doses of anesthetics are required
Objectives
Primary Objective
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations
Secondary Objectives
To evaluate whether fear mood anxiety familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention
Endpoints
Primary Endpoint
The need for any anesthetic or sedative medication during MRI examination
Secondary Endpoints
Visual analogue scales related to fear mood and familiarity willingness to take part in an MRI examination again
Study Population 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled
Description of SitesFacilities Enrolling Participants
The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University
Description of Study InterventionExperimental Manipulation
Our research will be conducted as a three arm randomized controlled trial VR booklet usual care Participants in the VR condition are immersed in a unique 360 VR experience specifically designed for this study
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination
In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods
Study Duration
36 months
Participant Duration
All participants need a single visit intervention to complete all study related tasks
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations or if anesthesia is needed less doses of anesthetics are required
Objectives
Primary Objective
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations
Secondary Objectives
To evaluate whether fear mood anxiety familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention
Endpoints
Primary Endpoint
The need for any anesthetic or sedative medication during MRI examination
Secondary Endpoints
Visual analogue scales related to fear mood and familiarity willingness to take part in an MRI examination again
Study Population 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled
Description of SitesFacilities Enrolling Participants
The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University
Description of Study InterventionExperimental Manipulation
Our research will be conducted as a three arm randomized controlled trial VR booklet usual care Participants in the VR condition are immersed in a unique 360 VR experience specifically designed for this study
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination
In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods
Study Duration
36 months
Participant Duration
All participants need a single visit intervention to complete all study related tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None