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Virtual Reality for Cervical Cancer Comfort During Brachytherapy

N/A
Recruiting
Led By Gary Lewis, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
Be older than 18 years old
Must not have
Known history of elevated intraocular pressure
History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Summary

This trial is testing if VR can help people during cancer treatment by distracting them from the pain and making them more comfortable.

Who is the study for?
This trial is for women aged 18 or older with a confirmed diagnosis of gynecologic cancer (like cervical cancer) that requires brachytherapy. Participants must be able to give written consent. It's not suitable for those with certain phobias, severe vision or hearing issues, history of seizures or motion sickness due to visual triggers, or any condition that would interfere with wearing a VR headset.Check my eligibility
What is being tested?
The study tests if using the Oculus Quest 2 Virtual Reality Headset during brachytherapy can improve patient satisfaction and reduce pain and the need for painkillers or anxiety medication. The goal is also to see how well VR technology fits into the clinical routine.See study design
What are the potential side effects?
While not directly related to treatment side effects, using VR may cause discomfort such as dizziness, nausea, eye strain, headaches in some individuals—especially those prone to motion sickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a gynecologic cancer that needs specific radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of high eye pressure.
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I have a history of seizures, severe motion sickness, dizziness, or migraines triggered by visual disturbances.
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I do not have claustrophobia, thalassophobia, cleithrophobia, or similar fears.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of eligible subjects who enroll onto the study.
The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety.
The number of subjects who withdraw or are withdrawn from the study.
+1 more
Secondary outcome measures
Benzodiazepine dose
Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety
Determination of VR distraction during brachytherapy treatment for cervical cancer pain
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sequence Group DExperimental Treatment1 Intervention
VR distraction occurring visits 2 and 3 with normal SOC therapy at visits 3 and 4.
Group II: Sequence Group CExperimental Treatment1 Intervention
VR distraction occurring visits 3 and 4 with normal SOC therapy at visits 1 and 2.
Group III: Sequence Group BExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 4 with normal SOC therapy at visits 2 and 3.
Group IV: Sequence Group AExperimental Treatment1 Intervention
VR distraction occurring visits 1 and 2 with normal SOC therapy at visits 3 and 4.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for cervical cancer include surgery, radiation therapy, and chemotherapy. Surgery involves the physical removal of cancerous tissues, which can range from a simple hysterectomy to more extensive procedures depending on the cancer's stage. Radiation therapy uses high-energy rays to target and kill cancer cells, often combined with chemotherapy to enhance its effectiveness. Chemotherapy involves the use of drugs to destroy cancer cells or stop their growth. These treatments are crucial for cervical cancer patients as they directly target and eliminate cancer cells, improving survival rates. The VR distraction technique being studied aims to reduce pain and anxiety during treatments like brachytherapy, a form of internal radiation therapy, thereby potentially improving patient experience and adherence to treatment protocols.
Primary or adjuvant chemoradiotherapy for cervical cancer with intraoperative lymph node metastasis - A review.Digital Self-Management Support Tools in the Care Plan of Patients With Cancer: Review of Randomized Controlled Trials.Streamlining follicular monitoring during controlled ovarian stimulation: a data-driven approach to efficient IVF care in the new era of social distancing.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
488 Previous Clinical Trials
150,449 Total Patients Enrolled
Gary Lewis, MDPrincipal InvestigatorUniversity of Arkansas
5 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Cervical Cancer Research Study Groups: Sequence Group A, Sequence Group B, Sequence Group C, Sequence Group D
~7 spots leftby Jul 2025
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