An interventional study of Virtual reality software in Breast Cancer and Pelvic Cancer, sponsored by Centre Hospitalier Departemental Vendee. Completed at 1 site in France. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Other
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.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 256 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Virtual reality session performed before the planning CT scan
Device: Virtual reality software
Normal care without intervention
The patient will undergo a 20-minute virtual reality session before the planning CT scan
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.
Time frame: 10 minute before the planning CT scan
| Milestone | Virtual Reality | Normal Care |
|---|---|---|
| Started | 128 | 128 |
| Completed | 120 | 122 |
| Not completed | 8 | 6 |
| Withdrew: Missing stai questionner | 8 | 6 |
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.
| score on a scale | Virtual Reality | Normal Care |
|---|---|---|
| Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management | 32 (30.2 to 33.7) | 36.2 (34.4 to 37.9) |
Collected over From the simulation CT scan to the first radiotherapy session (i.e 15 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Virtual Reality | 0/120 (0%) | 0/120 (0%) | 1/120 (0.8%) |
| Normal Care | 0/122 (0%) | 0/122 (0%) | 1/122 (0.8%) |
| Event | Virtual Reality | Normal Care |
|---|---|---|
| ClaustrophobiaGeneral disorders | 1/120 | 1/122 |
| Age, Continuous(years) | Virtual Reality | Normal Care | Total |
|---|---|---|---|
| Mean | 64 ± 12 | 66 ± 11 | 65 ± 12 |
| Sex: Female, Male(Participants) | Virtual Reality | Normal Care | Total |
|---|---|---|---|
| Female | 71 | 72 | 143 |
| Male | 57 | 56 | 113 |
| Race and Ethnicity Not Collected(Participants) | Virtual Reality | Normal Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Cancer type(Participants) | Virtual Reality | Normal Care | Total |
|---|---|---|---|
| Pelvis cancer | 64 | 64 | 128 |
| Breast cancer | 64 | 64 | 128 |
| BMI(kg/m²) | Virtual Reality | Normal Care | Total |
|---|---|---|---|
| Mean | 26.7 ± 4.4 | 26.2 ± 5.0 | 26.5 ± 4.7 |
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Centre Hospitalier Departemental Vendee