NCT07324577 · Wake Forest University Health Sciences
Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy
(RELAX)
What this study is about
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
View original scientific description
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants planned for radiation therapy for 15 or more treatments with non-neutron generating energies (10 MV or less) per study PI for prostate, breast, lung, or head and neck cancer. Neutrons have the potential to damage the VR headset device and are generated for energies above 10 MV.
- Age 18 years or older at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-33 or Karnofsky (KPS) 30-100 at the time of enrollment.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Exclusion criteria
- Previous radiation therapy
- VR device is determined to impede the radiation dosage during the VR device simulation and treatment planning
- Participants with primary brain tumors, brain metastases, and cancer involving the sinuses, orbits, nose, or ears, are excluded from this clinical trial because the VR device may obstruct the area being treated
- Participants with uncontrolled inter-current illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements per treating radiation oncologist.
- Participants with known epilepsy, significant motion sickness, severe uncorrected visual impairment, severe uncorrected hearing impairment, or seizures, per participant report.
- Participants with skin defects, infections, or open wounds in the area where the VR device is applied (face or scalp) or in the eyes per treating radiation oncologist.
- Participants with pacemakers, internal defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices. Radiation Therapists: Inclusion Criteria:
- Agreement to participate after reviewing the information sheet
- Radiation therapist at AHWFBCCC High Point who has treated at least one participant who enrolled on to the study and used the VR device.
Where
- High Point, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations