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NCT Number: NCT07427862

Virtual Reality (VR) for Interventional Radiology (IR) Procedures

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Procedural Anxiety Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location status: Recruiting

Location contact

Jeffrey Gold, PhD

CONTACT

[email protected]

323-361-4342

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Meta Oculus Quest Pro

Device

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 visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Pico 4

Device

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 tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Pico G3

Device

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 sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the Head-Mounted Display screen so that the immersion and presence will be increased. The Virtual reality glasses will be sanitized before every use so that the chance of infection will be minimized.

Primary outcomes

  1. Mean Change from baseline in Pain Intensity During Interventional Radiology Procedures

    Time frame: Baseline to 1 hour post-intervention

    Pain intensity will be assessed using the Faces Pain Scale - Revised (FPS-R), a validated self-report measure for children. The scale will be administered immediately before and after the intervention to evaluate changes in pain levels. Mean differences will be analyzed through paired samples t-test. 6 different faces representing various intensities of pain, ranging from "no pain" to "very much pain".

  2. Mean Change from baseline in Anxiety Intensity During Interventional Radiology Procedures

    Time frame: Baseline to 1 hour post-intervention

    Pain intensity will be assessed using the VAS Anxiety Scale and Childhood Anxiety Sensitivity Index (CASI), a validated self-report measure for children. The scale will be administered immediately before and after the intervention to evaluate changes in pain levels. Mean differences will be analyzed through paired samples t-test. scale from 1 - 10 with 10 being highest anxiety score.

  3. Mean satisfaction score for procedural success from caregivers.

    Time frame: 1-hour post-intervention

    Caregiver satisfaction will be assessed using a validated satisfaction questionnaire. 1) Not at all well 5) Moderately well 10) Extremely well.

  4. Mean distress score with the medical procedure given to participants.

    Time frame: 1-hour post-intervention

    Satisfaction survey scale of 1 (not at all well) to 10 (extremely well) how well procedure was managed.

Other outcomes

  1. Mean score in simulator sickness for participants.

    Time frame: 1-hour post-intervention

    The SSQ is a widely used questionnaire consisting of items related to potential side effects common to individuals after playing in virtual environments, such as "general discomfort," "headache," and "sweating." The questionnaire asks about symptoms currently experienced as rated on a 0-3 scale. An example item is: "How much is headache affecting you right now?" The total score indicates an individual's average rating, with higher scores indicating higher levels of simulator sickness.

  2. Mean score in virtual reality immersion for participants.

    Time frame: 1-hour post-intervention

    The GRIP assesses three domains: sense of involvement, perceived realism, and sense of transportation within the software. The measure contains 16 questions where patients can respond either "no," "a little," or "a lot." Higher total scores indicate a higher level of immersion.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Gareau

CONTACT

[email protected]

(323) 361-6208

Saloni M Dangoria

CONTACT

[email protected]

(323) 361-4342

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Mar 9, 2026

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.

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