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

Breast Cancer Clinical Trial

— REAVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269186
• Other study ID #: CHD22_0002
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: Agnès Dorion
• Phone: 251446380
• Email: agnes.dorion[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Pelvic Cancer
• Pelvic Neoplasms

Intervention

Device:
• Virtual reality software
The patient will undergo a 20-minute virtual reality session before the planning CT scan

Locations

Country	Name	City	State
France	CHD Vendée	La Roche-sur-Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 minute before the planning CT scan