Virtual Reality to Promote Relaxation Prior to Simulation

NCT06318338 | Completed Results DMC

• 2 other identifiers: UPCC 14523854756
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer

Keywords

Virtual Reality; Relaxation; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Situational Anxiety Prior to and After Use of VR Program (HADS)

  1 Day

• Patient Situational Anxiety Prior to and After Use of VR Program (STAI-6)

  1 Day

Study Arms (1)

Virtual Reality Program

EXPERIMENTAL

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

Interventions

Virtual Reality Program OTHER

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.

Virtual Reality Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Michael LaRiviere, MD
• Organization: Penn Medicine

Michael.lariviere@pennmedicine.upenn.edu

267-760-7895

Study Officials

• Michael LaRiviere, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: April 8, 2024
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)