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

NCT05440760 | Recruiting FDA Device

• 1 other identifier: 261231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Brachytherapy; Virtual Reality

Outcome Measures

Primary Outcomes (4)

• The number of eligible subjects who enroll onto the study.

  3 weeks

• The number of subjects who withdraw or are withdrawn from the study.

  3 weeks

• The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.

  3 weeks

• The number of times a technical problem occurs with the VR distraction

  3 weeks

Secondary Outcomes (4)

• Determination of VR distraction during brachytherapy treatment for cervical cancer pain

  3 weeks

• Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety.

  3 weeks

• Opiod dose

  3 weeks

• Benzodiazepine dose

  3 weeks

Study Arms (4)

Sequence Group A

EXPERIMENTAL

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

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group B

EXPERIMENTAL

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

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group C

EXPERIMENTAL

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

Device: The Oculus Quest 2 Virtual Reality Headset

Sequence Group D

EXPERIMENTAL

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

Device: The Oculus Quest 2 Virtual Reality Headset

Interventions

The Oculus Quest 2 Virtual Reality Headset 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 A; Sequence Group B; Sequence Group C; Sequence Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Study Officials

• Santanu Samanta, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph A Holley

CONTACT

501-686-8274; jaholley@uams.edu

Vernon Sincere

CONTACT

501-686-8274; vjsincere@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 1, 2022
• Study Start: August 8, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)