Recruiting

Virtual Reality

Sponsor:

University of Arkansas

Code:

NCT05440760

Conditions

Endocervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The Oculus Quest 2 Virtual Reality Headset

Study Details

Brief summary:

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.

Conditions

Endocervical Cancer

Study ID

NCT05440760

Start date

Aug 8, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Sequence Group A

VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

experimental: Sequence Group B

VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.

experimental: Sequence Group C

VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.

experimental: Sequence Group D

VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.

Interventions

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)

Primary outcome measure

  • The number of eligible subjects who enroll onto the study. [ Time Frame: 3 weeks ]
  • The number of subjects who withdraw or are withdrawn from the study. [ Time Frame: 3 weeks ]
  • The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety. [ Time Frame: 3 weeks ]
  • The number of times a technical problem occurs with the VR distraction [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Joseph A Holley

501-686-8274jaholley@uams.edu

Vernon Sincere

501-686-8274vjsincere@uams.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Joseph A Holley

501-686-8274jaholley@uams.edu

Matthew R Kovak

501-686-8274mrkovak@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Brachytherapy
  • Virtual Reality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-04-30.