Recruiting

Radiotherapy with Virtual Reality

Sponsor:

University of Miami

Code:

NCT06506435

Conditions

Anxiety

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Two Dimensional (2D) Informational Video

First-Person Virtual Reality Video

Third-Person Virtual Reality Video

Study Details

Brief summary:

The purpose of this research study is to investigate the impact of virtual reality experiences on individuals undergoing radiotherapy, aiming to assess whether this immersive technology can reduce anxiety and enhance patient overall treatment satisfaction. By comparing different virtual reality techniques and a standard informational video, the study seeks to identify optimal strategies for leveraging virtual reality to improve the patient experience during radiotherapy.

Conditions

Anxiety

Cancer

Study ID

NCT06506435

Start date

Dec 4, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Histologically proven cancer
2. ≥18 years of age
3. Able to speak and read English and/or Spanish
4. Receiving radiotherapy at the University of Miami

Exclusion Criteria:

1. Prior radiation therapy
2. Pregnant or nursing women
3. Men or women of childbearing potential who are unwilling to employ adequate contraception
4. Patients unable to consent or are prisoners
5. Participants with impaired decision-making capacity
6. Any serious illness or medical condition that would compromise patient safety during virtual reality as judged by the treating physician
7. Unwilling or unable to watch virtual reality video
8. Unwilling to fill out survey forms

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Informational Video

Participants in this group will watch a two-dimensional (2D) informational video that explains the radiation treatment process. Total participation is up to 8 weeks.

experimental: Virtual Reality: 1st Person Perspective

Participants in this group will have a virtual reality experience presented from a first-person perspective. Participants will wear a Meta Quest Pro virtual reality headset, immersing themselves in a scenario that replicates the radiation treatment process. Total participation is up to 8 weeks.

experimental: Virtual Reality: 3rd Person Perspective

Participants in this group will wear a Meta Quest Pro virtual reality headset and use virtual reality to observe the radiation treatment scenario from a standing position within the room, enabling them to witness both the CT scan and radiation machine from an external viewpoint. Total participation is up to 8 weeks.

Interventions

Two Dimensional (2D) Informational Video

A 30-minute informational video. The two dimensional (2D) video provides information about the radiotherapy process. Participants will receive this one-time intervention in-person, prior to treatment.

First-Person Virtual Reality Video

A 30-minute virtual reality video, experienced through a headset, provides an immersive portrayal of the radiotherapy process from a first-person perspective. Participants will receive this one-time intervention in-person, prior to treatment.

Third-Person Virtual Reality Video

A 30-minute virtual reality video, experienced through a headset, provides an immersive portrayal of the radiotherapy process from a third-person perspective. Participants will receive this one-time intervention in-person, prior to treatment.

Primary outcome measure

  • Change in Level of Anxiety measured by scores on the State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, up to 2 weeks ]

Central Contacts and Locations

Central contacts

Benjamin J Rich, MD

305-243-4200brich@miami.edu

Crystal Chen, PhD

305-243-4200ccc257@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Benjamin J Rich, MD

305-243-4200brich@miami.edu

Crystal Chen, PhD

305-243-4200ccc257@miami.edu

Principal Investigator:

Benjamin J Rich, MD

More Information

Sponsor

University of Miami

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-12-19.