About this trial
The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.
The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, ≥ 18 years of age
Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
Able to provide written consent
Disqualifiers
Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
Known history of elevated intraocular pressure
Claustrophobia, thalassophobia, cleithrophobia or similar phobias
Trial design
Parallel
Treatments tested in this trial
The Oculus Quest 2 Virtual Reality Headset
DeviceThe hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): * Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA) * TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA) * Nature Treks VR published by Greener Games (Ironbridge, England, UK)
Treatment groups
Trial outcomes
Primary outcomes
The number of eligible subjects who enroll onto the study.
The number of subjects who withdraw or are withdrawn from the study.
The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.
The number of times a technical problem occurs with the VR distraction
Secondary outcomes
Determination of VR distraction during brachytherapy treatment for cervical cancer pain
Compare the subject's procedural pain scores (using a visual analog scale \[VAS\] pre- and post-procedure) between sessions with VR and sessions without VR.
Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.
Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.
Opiod dose
Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents \[MMEs\]) between sessions with VR and sessions without VR.
Benzodiazepine dose
Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR
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