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In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years.
A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy.
Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination.
This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment.
The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan.
Virtual reality software seems to be a good alternative that requires fewer human resources.
The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Virtual reality session performed before the planning CT scan |
|
| Normal care | No Intervention | Normal care without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality software | Device | The patient will undergo a 20-minute virtual reality session before the planning CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management | Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale. | 10 minute before the planning CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa ZINZONI | vanessa.zinzoni@ght85.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHD Vendée | La Roche-sur-Yon | 85000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality | Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan |
| FG001 | Normal Care | Normal care without intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality | Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan |
| BG001 | Normal Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management | Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale. | Posted | Mean | 95% Confidence Interval | score on a scale | 10 minute before the planning CT scan |
|
From the simulation CT scan to the first radiotherapy session (i.e 15 days)
No adverse events related to the intervention (virtual reality headset) were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality | Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Claustrophobia | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ZINZONI Vanessa | Centre Hospitalier Départemental Vendée | 0251446285 | vanessa.zinzoni@ght85.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2024 | Sep 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 23, 2023 | Apr 2, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Normal care without intervention
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Cancer type | Count of Participants | Participants |
|
| BMI | Missing value in height or weight section, i.e. BMI cannot be calculated | Mean | Standard Deviation | kg/m² |
|
Normal care without intervention
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 1 |
| 120 |
| EG001 | Normal Care | Normal care without intervention | 0 | 122 | 0 | 122 | 1 | 122 |
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| D017437 |
| Skin and Connective Tissue Diseases |