Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

NCT ID: NCT05440760

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Endocervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Sequence Group A

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

Group Type: EXPERIMENTAL

The Oculus Quest 2 Virtual Reality Headset

Intervention Type: DEVICE

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)

Sequence Group B

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

Group Type: EXPERIMENTAL

The Oculus Quest 2 Virtual Reality Headset

Intervention Type: DEVICE

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)

Sequence Group C

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

Group Type: EXPERIMENTAL

The Oculus Quest 2 Virtual Reality Headset

Intervention Type: DEVICE

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)

Sequence Group D

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

Group Type: EXPERIMENTAL

The Oculus Quest 2 Virtual Reality Headset

Intervention Type: DEVICE

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)

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)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph A Holley

Role: CONTACT

jaholley@uams.edu

501-686-8274

Matthew R Kovak

Role: CONTACT

mrkovak@uams.edu

501-686-8274

Facility Contacts

Joseph A Holley

Role: primary

jaholley@uams.edu

501-686-8274

Matthew R Kovak

Role: backup

mrkovak@uams.edu

501-686-8274

Other Identifiers

261231

Identifier Type: -

Identifier Source: org_study_id