VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.
NCT03324958 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-02-08
Summary
This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.
Conditions
Interventions
- DEVICE
-
Virtual reality Helmet
The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.
- OTHER
-
No Virtual Reality Helmet
The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.
Sponsors & Collaborators
-
Gustave Roussy, Cancer Campus, Grand Paris
collaborator OTHER -
Centre Antoine Lacassagne
collaborator OTHER -
Institut de Cancérologie de la Loire
collaborator OTHER -
Centre Hospitalier Universitaire de Saint Etienne
lead OTHER
Principal Investigators
-
Nicolas Magné, PhD · Institut de Cancérologie Lucien Neuwirth
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-26
- Primary Completion
- 2020-12-01
- Completion
- 2021-03-04
Countries
- France
Study Locations
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