Children, Only, Anesthesia
Conditions
Keywords
MRI, Pediatrics, anesthesia, virtual reality
Brief summary
The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations. Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination. Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.
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 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.
Interventions
OTHERVR
The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience.
OTHERBooklet
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure.
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants cannot be blinded due to the nature of the study. The radiologists, anesthesiology team, MRI staff and the second research assistant administering post-procedure questionnaires and coding anesthesiology data intended to be blinded, however, children may disclose their group by talking about their experience.
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Informed assent and parental informed consent to participate in the study. 2. Stated willingness to participate in the intervention and to complete study questionnaires. 3. Inpatient or outpatient at the Pediatric Center. 4. Age 4-18 years 5. Scheduled for MRI examination under anesthesia at the Semmelweis University. 6. Fluent in Hungarian language
Exclusion criteria
1. Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience. 2. In case of epilepsy, if the treating physician recommend against participation. 3. Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions. 4. Inpatients, if the treating physician indicates that the child is too unwell for the study. 5. Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of children requiring anesthesia | during the MRI examination, assessed directly after the MRI from anesthesiology documentation | proportion of children requiring any form of anesthesia or sedation during the MRI examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mood | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | mood of the child measured on a visual analogue scale, scale range 1-100, higher indicating better mood |
| nervousness | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | nervousness of the child measured on a visual analogue scale, scale range 1-100, higher increased nervousness |
| fear | assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | fear of the child measured on a visual analogue scale range 1-100, higher indicating increased fear |
| willingness to take part again | no later than 4 hours after the MRI examination | willingness of the child to take part in a future MRI examination measured on a visual analogue scale, scale range 1-100, higher indicating more willingness taking part in a future MRI examination |
| helpfulness | directly before the MRI examination | indication how much the child found the preparation method helpful, measured on a visual analogue scale, scale range 1-100, higher indicating the preparation method was more helpful |
| familiarity | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | familiarity of the child with the MRI examination measured on a visual analogue scale scale range 1-100, higher indicating increased familiarity with the MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| familiarity of the child assessed by parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | familiarity of the child with the MRI examination assessed by parent measured on a visual analogue scale, scale range 1-100, higher indicating increased familiarity with the MRI |
| fear of the parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | fear of the parent measured on a visual analogue scale, range 1-100, higher indicating increased fear |
| propofol dose | during the MRI examination, assessed from anesthesiology documentation 1 day after the MRI at the latest | Dose of propofol used per body weight and duration of MRI examination. |
| mood of the parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | mood of the parent measured on a visual analogue scale, scale range 1-100, higher indicating better mood |
| nervousness of the parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | nervousness of the parent measured on a visual analogue scale, scale range 1-100, higher increased nervousness |
| familiarity of the parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | familiarity of the parent with the MRI examination measured on a visual analogue scale, scale range 1-100, higher indicating increased familiarity with the MRI |
| fear of the child assessed by parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | fear of the child assessed by parent measured on a visual analogue scale, range 1-100, higher indicating increased fear |
| mood of the child assessed by parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | mood of the child assessed by parent measured on a visual analogue scale, scale range 1-100, higher indicating better mood |
| nervousness of the child assessed by parent | directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination | nervousness of the child assessed by parent measured on a visual analogue scale, scale range 1-100, higher increased nervousness |
Countries
Hungary
Contacts
Primary ContactKlara Horvath, MD PhD
Backup ContactSandor Erdos, MD
Outcome results
None listed