Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy

NCT ID: NCT05269186

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2024-07-04

Brief Summary

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.

Conditions

Breast Cancer; Pelvic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Virtual reality

Virtual reality session performed before the planning CT scan

Group Type: EXPERIMENTAL

Virtual reality software

Intervention Type: DEVICE

The patient will undergo a 20-minute virtual reality session before the planning CT scan

Normal care

Normal care without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality software

The patient will undergo a 20-minute virtual reality session before the planning CT scan

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)

2. Patient ≥ 18 years old,

3. Patient who has the capacity to understand the protocol and has given written consent to participate in the research,

4. Patient with social security coverage.

Exclusion Criteria

1. Metastatic patients

2. Patients with previous radiotherapy

3. Patients with a diagnosis of hearing impairment

4. Patients with major cognitive disorders (such as dementia)

5. Psychiatric pathology such as schizophrenia

6. Patients with epilepsy or hypersensitivity to flashing lights

7. Patient with a pacemaker, hearing aid or defibrillator

8. Claustrophobic patients

9. Patients sensitive to motion sickness

10. Patients who are visually impaired or blind

11. Patients with migraine

12. Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes

13. Patients under guardianship, curators or deprived of liberty

14. Non French speaking patient

15. Illiterate patient

16. Patient participating in another clinical investigation or interventional clinical research protocol involving a drug

17. Pregnant or breastfeeding patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa ZINZONI

Role: PRINCIPAL_INVESTIGATOR

vanessa.zinzoni@ght85.fr

Locations

CHD Vendée

La Roche-sur-Yon, , France

Countries

France

Other Identifiers

CHD22_0002

Identifier Type: -

Identifier Source: org_study_id