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Trial Title:
Virtual Reality to Promote Relaxation Prior to Simulation
NCT ID:
NCT06318338
Condition:
Cancer
Conditions: Keywords:
Virtual Reality
Relaxation
Mindfulness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Virtual Reality Program
Description:
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.
Arm group label:
Virtual Reality Program
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).
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.
Criteria for eligibility:
Criteria:
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
- Has a history of motion sickness, car sickness, vertigo, epilepsy, seizures,
migraines, or light sensitivity
- Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing
loss
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Perelman Center for Advanced Medicine
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ching Lai
Phone:
267-250-9244
Email:
Ching.Lai@pennmedicine.upenn.edu
Start date:
April 8, 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06318338