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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Arkansas

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Sequence Group AExperimental treatment 1 intervention
Group B: Sequence Group BExperimental treatment 1 intervention
Group C: Sequence Group CExperimental treatment 1 intervention
Group D: Sequence Group DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number of eligible subjects who enroll onto the study.

Time frame
3 weeks
2

The number of subjects who withdraw or are withdrawn from the study.

Time frame
3 weeks
3

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

Time frame
3 weeks
4

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

Time frame
3 weeks

Secondary outcomes

1

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.

Time frame
3 weeks
2

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.

Time frame
3 weeks
3

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.

Time frame
3 weeks
4

Benzodiazepine dose

Compare the dose(s) of benzodiazepine anxiolytics per session (using a benzodiazepine conversion calculator) between sessions with VR and sessions without VR

Time frame
3 weeks

Other outcomes

Sponsors and contacts

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