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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

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