Skip to main content
OpenTrials
Completed

NCT Number: NCT06318338

Virtual Reality to Promote Relaxation Prior to Simulation

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of a Pre-simulation VR Platform Prior to Radiation

    Time frame: 1 Day

    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.

Secondary outcomes

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

    Time frame: 1 Day

    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.

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

    Time frame: 1 Day

    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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.