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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Virtual Reality | Five minutes before the procedure and wear it throughout the procedure and can keep it on up to two minutes after procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from baseline in Pain Intensity During Interventional Radiology Procedures | 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". | Baseline to 1 hour post-intervention |
| Mean Change from baseline in Anxiety Intensity During Interventional Radiology Procedures | 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. | Baseline to 1 hour post-intervention |
| Mean satisfaction score for procedural success from caregivers. | Caregiver satisfaction will be assessed using a validated satisfaction questionnaire. 1) Not at all well 5) Moderately well 10) Extremely well. | 1-hour post-intervention |
| Mean distress score with the medical procedure given to participants. | Satisfaction survey scale of 1 (not at all well) to 10 (extremely well) how well procedure was managed. | 1-hour post-intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean score in simulator sickness for participants. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Pediatric and adult patients undergoing interventional radiology (IR) procedures at Children's Hospital Los Angeles (CHLA), along with legal guardians of participating pediatric patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saloni M Dangoria | Contact | (323) 361-4342 | sdangoria@chla.usc.edu | |
| Elena Gareau | Contact | (323) 361-6208 | egareau@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Gold, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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| 1-hour post-intervention |
| Mean score in virtual reality immersion for participants. | 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. | 1-hour post-intervention |