Virtual Reality (VR) for Interventional Radiology (IR) Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meta Oculus Quest Pro, Pico 4, Pico G3.
- Who it may be relevant to
- Registry conditions: Pain, Procedural Anxiety. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to to utilize Virtual Reality during their interventional radiology procedure to help reduce any pain and anxiety experienced during the procedure in patients above the age of 8 undergoing interventional radiology procedures. The main questions it aims to answer are: * To determine if Virtual Reality is more effective than standard care for reducing pain and anxiety in children undergoing painful interventional radiology procedures. It is hypothesized that children in the Virtual Reality condition will experience reduced pain and anxiety compared to children receiving standard of care. * To evaluate caregiver's assessment of patient distress and their satisfaction with Virtual Reality compared to standard of care. It is hypothesized that caregiver satisfaction with the medical procedure will be significantly greater in the Virtual Reality group compared to the standard of care group. It is hypothesized that caregivers will perceive lower pain/anxiety when their child receives Virtual Reality compared to standard of care. Participants will complete pre and post surveys before and after interventional radiology procedures. Participants will use Virtual Reality headsets while undergoing procedure.
Interventions
- Device Meta Oculus Quest Pro
Participants 10 and older can use the Meta Oculus Quest Pro headset. The headset contains content that is appropriate for patients of 10 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visua - Device Pico 4
Participants 8-18 can use the Pico 4 headset. The headset contains content that is appropriate for patients aged 8-18 with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and t - Device Pico G3
Participants 13 and older can use the Pico G3 headset. The headset contains content that is appropriate for patients of 13 and older with no developmental delays. The visual a bright, vibrant color and a quality image. The Virtual reality game is equipped enables the player to look around the virtual environment. In addition, there is the option to interact with the Virtual reality environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory
Primary outcome measures
- Mean Change from baseline in Pain Intensity During Interventional Radiology Procedures [Time frame: Baseline to 1 hour post-intervention]
- Mean Change from baseline in Anxiety Intensity During Interventional Radiology Procedures [Time frame: Baseline to 1 hour post-intervention]
- Mean satisfaction score for procedural success from caregivers. [Time frame: 1-hour post-intervention]
- Mean distress score with the medical procedure given to participants. [Time frame: 1-hour post-intervention]
Eligibility criteria
Inclusion criteria
- Children who are at least 8 years old
- Children who are English speaking with caregivers who are English speaking or Spanish speaking.
- Children who are undergoing an interventional radiology procedure are eligible to participate in this project.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
Exclusion criteria
- Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
- Children with a psychiatric disorder, organic brain syndrome, intellectual disability, or other known cognitive/neurological disorders
- Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children with a history of seizure disorder.
- Children currently sick with flu-like symptoms or experiencing a headache or earache.
- Children with known or suspected motion sickness.
- Children with cochlear implants or pacemakers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Los Angeles — Los Angeles
Identifiers
NCT: NCT07427862 · CHLA-25-00315