Skip to main content
OpenTrials
Completed

NCT Number: NCT05086263

Effects of Virtual Reality MRI Preparedness

Magnetic resonance imaging is an important and increasingly prevalent imaging modality used in healthcare. Children often find the procedure anxiety provoking causing difficulty in staying still and providing quality images. The use of preparation techniques including play therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce anxiety and facilitate better image quality. Modalities of preparation including Virtual Reality (VR) pose as an alternative to habituate children for a MRI procedure.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Educational Problems Mental Disorders

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child is between the ages of 8-9 years inclusive
  • Child scheduled for a clinical MRI at CHLA.

Exclusion criteria

  • Child is younger than 8 years or older than 9 years. These are the bottom end of age ranges that are frequently sedated.
  • Children who have metal in their bodies that cannot participant in an MRI.
  • Medical history that may affect brain development that may confound ability to complete an MRI without sedation.
  • Children suffering from epilepsy or history of seizures who may react poorly to a virtual reality intervention.
  • Child who has a history of MRI acquisition where habituation and preparedness may not be needed.
  • Child with English as a second language due to restrictions of research team.
  • Child with implantable medical devices or personal medical devices that may be affected by the study device's radio waves

Treatment and study plan

PICO G2 4k

Device

On this virtual reality headset, it will be loaded with an educational virtual reality mock MRI training titled "Ready Teddy". This training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Furthermore, using audio/visual cues, when the viewer moves their head too much in a MRI like setting they are reminded to stay still. Biofeedback training is aimed to mimic the experience of the MRI with real audio recordings of image acquisition, in order to adequately train the view to stay still in an MRI procedure.

Primary outcomes

  1. Childhood Anxiety Sensitivity Index (CASI)

    Time frame: Approximately 5 minutes to one hour before procedure

    This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.

  2. Number of Participants with Successful Imaging without Sedation

    Time frame: Up to thirty minutes after intervention

    A successful image will be produced after MRI. Failure would mean the child is rescheduled for another MRI with sedation.

  3. Visual Analogue Scale (VAS)

    Time frame: Approximately 5 minutes to one hour before intervention

    The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children

  4. Faces Pain Scale-Revised (FPS-R)

    Time frame: Approximately 5 minutes to one hour before procedure

    Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.

  5. Child Anxiety Meter State (CAM-S)

    Time frame: Approximately 5 minutes to one hour before procedure

    The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they feel at the moment. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.

  6. Child Anxiety Meter Trait (CAM-T)

    Time frame: Approximately 5 minutes to one hour before procedure

    The child is asked to color a thermometer that has ten marks to indicate their level of anxiety they usually feel at home. The meter can be translated to a 0-10 scale with higher score indicating greater anxiety.

Secondary outcomes

  1. Demographics

    Time frame: Up to one hour before intervention

    24 Item questionnaire which asks parents demographic questions regarding socioeconomic data.

Other outcomes

  1. Satisfaction Questionnaire

    Time frame: Immediately after intervention

    45 item questionnaire using a four point scale (strongly agree, agree, disagree, and strongly disagree) to gauge ease of use and satisfaction using the VR headset. Higher scores reflect greater satisfaction.

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2021
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.