NCT04419077

Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to improve cancer patient well-being in a drug-free manner. The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This level anxiety is particularly high before invasive acts but also before chemotherapy by side effects anticipation. Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however requires on site specialists to be available whenever needed. Virtual reality provides a distractive environment enabled to shift patient focus. It can support a switch of patient mindset by providing positive emotions. Since 5 years, this disruptive technology is being more and more used as medical support thanks to a new generation of headsets enabling improved performance at cheaper prices. Many publications have now demonstrated the positive impact of virtual reality to take in charge patients' pain or pre-operational anxiety.

Detailed description

The primary objective of the REV study is to demonstrate the difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y) before patients undergo an oncological procedure (invasive act or chemotherapy (C1D1). The investigator's REV study aims to recruit 66 patients among three cohorts (22 patients per cohort) in 12 months. * Breast cancer cohort (patient receiving an adjuvant or neoadjuvant chemotherapy with doxorubicin and cyclophosphamide) * Head or neck cancer cohort (patient treated by concomitant radiochemotherapy) * Cancer patient for which an invasive act inducing anxiety is planned (lumbar puncture, ascites puncture, thoracocentesis, myelogram, bone marrow biopsy, urinary catheterization, ..) The REV study aims to impact Lyon's hospital patients' quality of life and well-being by decreasing their anxiety level during oncological treatments thanks to innovative supportive cares.

Conditions

• Anxiety
• Chemotherapy Effect
• Breast Cancer
• Head Cancer Neck

Interventions

Type	Name	Description
BEHAVIORAL	Virtual reality exposure	Patients will be exposed to a 10-20 min virtual reality session just before an oncological procedure (invasive act or chemotherapy). Patients will be able to choose between 4 virtual universes (beach, underwater, forest, space) and seven musical content.

Timeline

• Start date: 2020-06-07
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2020-06-05
• Last updated: 2023-09-05

Locations

1 site across 1 country: France