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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 - Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sequence Group A 		VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.
  • Device: The Oculus Quest 2 Virtual Reality Headset
    The 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)
Experimental
Sequence Group B 		VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.
  • Device: The Oculus Quest 2 Virtual Reality Headset
    The 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)
Experimental
Sequence Group C 		VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.
  • Device: The Oculus Quest 2 Virtual Reality Headset
    The 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)
Experimental
Sequence Group D 		VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.
  • Device: The Oculus Quest 2 Virtual Reality Headset
    The 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)

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Joseph A Holley
501-686-8274
jaholley@uams.edu

More Details

NCT ID
NCT05440760
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Joseph A Holley
501-686-8274
jaholley@uams.edu

Detailed Description

This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight. The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not: - Sequence Group A will be treated according to schedule VVNN. - Sequence Group B will be treated according to schedule VNNV. - Sequence Group C will be treated according to schedule NNVV. - Sequence Group D will be treated according to schedule NVVN.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.