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NCT Number: NCT05440760

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

    Time frame: 3 weeks

    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.

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

    Time frame: 3 weeks

    Compare the subject's procedural anxiety scores (using a VAS pre- and post-procedure) between sessions with VR and sessions without VR.

  3. Opiod dose

    Time frame: 3 weeks

    Compare the dose(s) of opioid pain medication per session (using morphine milligram equivalents [MMEs]) between sessions with VR and sessions without VR.

  4. Benzodiazepine dose

    Time frame: 3 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph A Holley

CONTACT

[email protected]

501-686-8274

Vernon Sincere

CONTACT

[email protected]

501-686-8274

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 1, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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