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Virtual Reality Preparation for MRI-Related Anxiety

N/A

Recruiting

Research Sponsored by Children's Hospital Colorado

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 6-7 years who are scheduled for an MRI scan of specified body parts without anesthesia and without contrast

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after mri scan

Awards & highlights

Study Summary

This trial will test whether VR can help reduce kids' stress during MRI scans.

Who is the study for?

This trial is for children aged 6-17 who are scheduled for an MRI scan without anesthesia or contrast. It's not suitable for non-English speakers, those with cognitive impairments that prevent using VR or outcome tools, or visual impairments not correctable by lenses.Check my eligibility

What is being tested?

The study tests if virtual reality (VR) can better prepare kids and reduce distress during MRI scans compared to no preparation, Child Life-led prep, or watching a preparation video. Kids will be randomly placed in one of four groups to compare methods.See study design

What are the potential side effects?

While the trial does not involve medication and thus has minimal risk of side effects, some potential discomforts may include dizziness or nausea from VR use and possible anxiety from participating in the preparation sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 6-7 years old and scheduled for an MRI without anesthesia or contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected while patient is mri scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected while patient is mri scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected while patient is mri scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Anxiety Rating

Demographic Information

MRI Scan Quality

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: MRI preparation videoExperimental Treatment1 Intervention

Participants will be shown an MRI preparation video by the research coordinator in the MRI dressing room prior to MRI scan. The MRI preparation video will walk the patient through the MRI experience with a mock patient explaining all the steps of MRI process from check in to discharge. The child life specialist will not meet with the caregiver or child during their visit.

Group II: Child Life-led preparationExperimental Treatment1 Intervention

Participants will meet with a child life specialist who will provide psychological preparation utilizing photos, MRI sounds, verbal discussion of MRI process, and discuss various coping strategies such as deep breathing or stress ball and option to watch a movie for alternative focus/distraction during the scan.

Group III: Child Life preparation with VRExperimental Treatment2 Interventions

Participants will be provided MRI preparation with a child life specialist using the Kind VR device. The VR (virtual reality) session will consist of an audio and visual MRI experience designed to serve as an opportunity for the patient to practice their scan prior to MRI. The VR session will take place once during the Radiology admission and will be approximately 15 minutes in duration. The VR software was developed by Kind VR and was designed specifically for the purpose of preparation for brain MRI. The interactive VR experience walks patients through each step of an MRI. Patients can practice holding still for the MRI and will get feedback from the VR headset when they are moving their head. Along with VR practice session CCLS will discuss various coping strategies such as deep breathing and/or stress ball and option to watch a movie for alternative focus/distraction during the scan.

Group IV: Current standard of care, no formal preparationActive Control1 Intervention

Participants in this group will receive the standard of care with no formal preparation. MRI technologist will meet patient prior to scan introducing role of patient, role of MRI technician, and give verbal discussion of MRI process. MRI technologist will offer opportunity for patient to watch a movie as alternative focus/distraction during MRI scan. The child life specialist will not meet with the caregiver or child during their visit.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital ColoradoLead Sponsor

116 Previous Clinical Trials

5,132,516 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research extend to elderly individuals over eighty years of age?

"The trial is looking for participants aged between 6 and 17 years old. On the other hand, there are 93 investigations that focus on individuals younger than 18 and 268 studies dedicated to seniors over 65."

Answered by AI

What is the scale of this trial in terms of participant numbers?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical study which initially appeared on July 15th 2020 is still recruiting patients. The research requires 280 individuals from 1 site to take part in the trial."

Answered by AI

Are there any unfilled slots in this clinical trial available for individuals?

"Affirmative. According to clinicaltrials.gov, this medical study has been open for recruitment since July 15th 2020 and was recently updated on September 15th 2023. The trial requires 280 participants across a single site to participate."

Answered by AI

Am I eligible to be enrolled in this medical experiment?

"This trial is open to 280 individuals aged 6-17 suffering from anxiety. Those that wish to participate must meet the following criteria: (1) be prepared for a MRI scan without anesthetic or contrast, and (2) fall within the specified age range of 6-17 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using Virtual Reality Simulation to Prepare Children Undergoing MRI

Brianne Newman 2020. "Using Virtual Reality Simulation to Prepare Children Undergoing MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04402216.

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