Virtual Reality to Promote Relaxation Prior to Simulation

Virtual Reality to Promote Mindfulness and Relaxation Prior to Radiation Simulation: A Prospective Pilot Feasibility Study

The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Virtual Reality Program

Detailed Description

The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT. The investigators hypothesize that this intervention will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes' length is likely to be tolerated by most patients and likely to provide benefit. The maximum length of the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises.

As this is a feasibility study, investigators and participants will not be blinded to study procedures. Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. This is a single site study. No interim analyses or sub-studies are planned. Based on the expected accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet the conditions described above.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman Center For Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments
2. Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM)
3. Adults, at least 18 years of age
4. Performance Status (ECOG) 0-2

Exclusion Criteria:

1. Prior radiotherapy
2. History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the last 6 months
3. History of epilepsy and seizures
4. Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is not treated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality Program; This is a single arm study. All participants will participate in the study intervention, which involves experiencing a virtual reality program.

Other: Virtual Reality Program; Study participants will be provided a HTC or Pico VR head-mounted device (HTC Flow, HTC Focus or Pico Neo Pro) which will be fitted for comfort. Patients will remain seated for the entirety of the VR program. The program generally takes about ten minutes to complete but may last up to 11 minutes. The program displays a relaxing environmental setting with narration based in mindfulness meditation principles. Subjects will be prompted to practice breathing exercises designed to relax and reduce anxiety.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a Pre-simulation VR Platform Prior to Radiation	Feasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Situational Anxiety Prior to and After Use of VR Program (HADS)	Prior to the intervention, patients completed the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire that includes two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D), each rated on a 0-3 scale. Raw scores range from 0-21 with higher scores indicating higher anxiety or depression, for each subscale respectively. Scores on a scale greater than eight indicate clinically significant anxiety or depression. This survey was only delivered at one time-point which was prior to use of the VR program.	1 Day
Patient Situational Anxiety Prior to and After Use of VR Program (STAI-6)	The State-Trait Anxiety Inventory (STAI-6) is a validated short form of the 20-item STAI 6-item questionnaire. It contains six items ("I am tense", "I feel upset", "I am relaxed", "I feel content", "I am worried", "I feel calm.") rated on a 1-4 Likert scale to assess situational anxiety. Raw scores range from 6-24, with higher scores indicating higher situational anxiety. Total STAI-6 scores are multiplied by 20 and divided by six to give a score between 20-80, consistent with the 20-item questionnaire. Scores on a scale of 40 or higher is correlated with clinically significant anxiety. The STAI-6 was delivered at two time-points, prior to and after use of the VR program.	1 Day

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Michael LaRiviere, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Relaxation; Virtual Reality
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UPCC 14523; 854756 (Other Identifier: Penn IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No