Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud
Pierre-Bénite, 69495, France
NCT Number: NCT04419077
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pierre-Bénite, 69495, France
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For all patients:
For breast cancer cohort :
For head, neck and bladder cancer cohort :
For invasive act leading to potential anxiety cohort :
Patient for whom an invasive act leading to potential anxiety is planned (excluding percutaneous implantable chamber) :
Exclusion criteria
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.
Time frame: Before an invasive act or a chemotherapy
Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).
Time frame: Before an invasive act or a chemotherapy
Difference of anxiety before and after a virtual reality exposure using a self-evaluation anxiety inventory before patients undergo an oncologic procedure (invasive act or chemotherapy (C1D1).
Comparison of responses between self-evaluation anxiety inventory before and after virtual reality exposure just before an oncologic procedure (invasive act or a chemotherapy)
Time frame: Just before chemotherapy
Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo chemotherapy (C1D1, C2D1, C3D1).
Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before chemotherapy
Time frame: Just before an invasive act
Difference of anxiety before and after a virtual reality exposure using the State-Trait Anxiety Inventory (STAI-Y; A-State Scale) or the Self-evaluation anxiety inventory before patients undergo an invasive act.
Comparison of responses between the STAI-Y; A-State Scale or the Self-evaluation anxiety inventory before and after virtual reality exposure just before an invasive act
Time frame: Just before an oncologic procedure
Patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncologic procedure (invasive act or a chemotherapy).
Quotation of patient basal anxiety level using STAI-Y; A-State Scale, STAI-Y; Trait-State Scale or the Self-evaluation anxiety inventory just before an oncological procedure (invasive act or a chemotherapy)
Time frame: just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy
Determination of patient anxiety level evolution through 3 cycles of chemotherapy using the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory (just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy).
Comparison of responses between the STAI-Y; A-State Scale and the Self-evaluation anxiety inventory before virtual reality exposure, after virtual reality exposure and after 1 hour of chemotherapy
Hospices Civils de Lyon
Other
Acronym: REV
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.
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