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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality exposure | Other | Virtual reality exposure just before an oncological procedure (invasive act or a chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of anxiety using the State-Trait Anxiety Inventory before oncologic procedure | 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). | Before an invasive act or a chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of anxiety using a self-evaluation anxiety inventory before oncologic procedure | 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) |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud | Pierre-Bénite | 69495 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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44 patients for the cohort " chemotherapy " and 22 patients for the cohort " invasive act ".
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|
| Before an invasive act or a chemotherapy |
| Difference of anxiety using the State-Trait Anxiety Inventory 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 | Just before chemotherapy |
| Difference of anxiety using the State-Trait Anxiety Inventory before 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 | Just before an invasive act |
| Patient basal anxiety level 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) | Just before an oncologic procedure |
| Determination of patient anxiety level evolution through 3 cycles 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 | just before virtual reality exposure, after virtual reality exposure, after 1 hour of chemotherapy |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |