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NCT04402216 · ClinicalTrials.gov registry record · NA

Using Virtual Reality Simulation to Prepare Children Undergoing MRI

A NA study, sponsored by Children's Hospital Colorado.

Completed
Registry status
NA
Development phase
165
Enrollment target

NCT04402216: Completed NA study, sponsored by Children's Hospital Colorado.

NCT04402216 is a NA study that has completed, run by Children's Hospital Colorado. The registered enrollment target is 165 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04402216, a NA study, has completed, sponsored by Children's Hospital Colorado.

COMPLETED
Registry status
NA
Development phase
165 participants
Enrollment target

Study Summary

This study will evaluate the effectiveness of using virtual reality (VR) to reduce distress in pediatric patients undergoing MRI scans compared to other methods of preparation. Children will be divided into four groups. The investigators hypothesize the children who receive Child Life preparation with VR will experience decreased distress compared to the other 3 treatment groups (no formal preparation, Child Life-led preparation, and MRI preparation video). The investigators also hypothesize that children who receive Child Life-led preparation will experience better decreased distress than current standard of care (no formal preparation) and MRI preparation video.

Primary Outcome

Pre-procedural anxiety level of the child will be collected via child self-report and staff report before the MRI scan. Patient and Staff will report child's anxiety using a Visual Analog Scale with anchors "Not Anxious" and "Very Anxious." VAS scores will range from 1-100, with lower scores indicating less anxiety.

Interventions

  • BEHAVIORAL Child Life-led preparation
  • BEHAVIORAL MRI preparation video
  • BEHAVIORAL KindVR Virtual Reality MRI Preparation Experience

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2020-07-15
Est. Completion 2024-05-01
Phase NA
Children's Hospital Colorado

7 total trials

What the finished NCT04402216 record still lists

NCT04402216 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 3 interventions - of which Child Life-led preparation is the first listed.

NCT04402216 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04402216 about?

NCT04402216 is a clinical study titled "Using Virtual Reality Simulation to Prepare Children Undergoing MRI". This study will evaluate the effectiveness of using virtual reality (VR) to reduce distress in pediatric patients undergoing MRI scans compared to other methods of preparation. Children will be divided into four groups. The investigators hypothesize the children who receive Child Life preparation wi...

What is the current status of trial NCT04402216?

This trial is currently completed. It is a NA study. The enrollment target is 165 participants. The study started on 2020-07-15. Estimated completion is 2024-05-01.

What interventions are being tested in trial NCT04402216?

The interventions under investigation include: Child Life-led preparation (BEHAVIORAL), MRI preparation video (BEHAVIORAL), KindVR Virtual Reality MRI Preparation Experience (BEHAVIORAL).

Who is sponsoring clinical trial NCT04402216?

This trial is sponsored by Children's Hospital Colorado, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04402216's enrollment target sits among peer trials

165 626th of 2000 higher than 1,375 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04402216, the US trial registry maintained by the National Library of Medicine. NCT04402216 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.