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Effects of Virtual Reality MRI Preparedness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086263
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
Lumeum Inc.
Information provided by (Responsible Party):
Children's Hospital Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Educational Problems Device: Pico G2 4k Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A schedule of randomization matching and stratified in age and gender will be computer generated and used to determine which group the child will be placed in. Neither the investigator nor child will know which group they are in until after the parent and child complete the first set of questionnaires
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Virtual Reality MRI Preparedness
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Standard of Care (No VR) Randomization
Participants would take the same questionnaires as the VR interventional group except the RT questionnaire. Then they will proceed with their MRI.
Experimental: VR Randomization
The virtual reality MRI training will be conducted immediately after completion of the questionnaires in a distraction free room. The training explains the procedure to the viewer and addresses common questions that individuals often have regarding an MRI. Using audio/visual cues and 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. The research subject will continue with their regularly scheduled MRI. The modified Yale Preoperative Anxiety Scale (mYPAS) is an observational measure and will be completed by research staff.
Device: Pico G2 4k
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 Outcome Measures :
  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 Outcome Measures :
  1. Demographics [ Time Frame: Up to one hour before intervention ]
    24 Item questionnaire which asks parents demographic questions regarding socioeconomic data.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086263


Contacts
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Contact: Nhat Ngo, BS BA 3233616244 nngo@chla.usc.edu

Sponsors and Collaborators
Children's Hospital Los Angeles
Lumeum Inc.
Investigators
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Principal Investigator: Jeffrey I Gold, PhD Children's Hospital Los Angeles
Additional Information:
Publications:
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Responsible Party: Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT05086263    
Other Study ID Numbers: CHLA-21-00107
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Los Angeles:
Virtual Reality
Magnetic resonance imaging
Radiology