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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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
• Устройство 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

Первичные конечные точки

• Mean Change from baseline in Pain Intensity During Interventional Radiology Procedures [Срок оценки: Baseline to 1 hour post-intervention]
• Mean Change from baseline in Anxiety Intensity During Interventional Radiology Procedures [Срок оценки: Baseline to 1 hour post-intervention]
• Mean satisfaction score for procedural success from caregivers. [Срок оценки: 1-hour post-intervention]
• Mean distress score with the medical procedure given to participants. [Срок оценки: 1-hour post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07427862 · CHLA-25-00315

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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