NCT04402216

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

3.8 years

First QC Date

March 26, 2020

Last Update Submit

February 18, 2025

Conditions

AnxietyDistress

Keywords

anxietydistressvirtual realityMRIpediatricschild lifecertified child life specialistVRpreparation

Outcome Measures

Primary Outcomes (1)

  • Anxiety Rating

    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.

    immediately before MRI scan

Secondary Outcomes (6)

  • Visit Satisfaction

    immediately after MRI scan

  • Demographic Information

    collected retrospectively within 24 hours after verbal consent is obtained

  • MRI Scan Quality

    immediately after MRI scan

  • Technician feedback

    immediately after MRI scan

  • Anxiety Rating

    immediately after MRI scan

  • +1 more secondary outcomes

Study Arms (4)

Current standard of care, no formal preparation

NO 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.

Child Life-led preparation

EXPERIMENTAL

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.

Behavioral: Child Life-led preparation

MRI preparation video

EXPERIMENTAL

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.

Behavioral: MRI preparation video

Child Life preparation with VR

EXPERIMENTAL

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.

Behavioral: Child Life-led preparationBehavioral: KindVR Virtual Reality MRI Preparation Experience

Interventions

Child Life-led preparationBEHAVIORAL

Support from a certified child life specialist in preparation for MRI

Child Life preparation with VRChild Life-led preparation
MRI preparation videoBEHAVIORAL

A descriptive video about what to expect when undergoing MRI

MRI preparation video
KindVR Virtual Reality MRI Preparation ExperienceBEHAVIORAL

A VR experience to prepare pediatric patients for MRI, to be used in addition to support from a certified child life specialist

Child Life preparation with VR

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • (1) patients aged 6- 7 years who are scheduled for an MRI scan of the brain, face, orbitals, neck, spine, lower extremity, hip, humerus, knee, tibia and fibula, ankle, shoulder, elbow, forearm, hand, and/or wrist.
  • (2) without anesthesia and
  • (3) without contrast

You may not qualify if:

  • (1) cognitive impairment that negates the use of the outcome tools or use of virtual reality device;
  • (2) visual impairment that could not be corrected by lenses;
  • (3) non-English speaking parent or patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Certified Child Life Specialist

Study Record Dates

First Submitted

March 26, 2020

First Posted

May 26, 2020

Study Start

July 15, 2020

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

IDP will not be shared with other researchers.

Locations

US(1)