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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Pelvic Cancer
• Intervention / Treatment: Device: Virtual reality software

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France, 85000
    • CHD Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality; Virtual reality session performed before the planning CT scan	Device: Virtual reality software; The patient will undergo a 20-minute virtual reality session before the planning CT scan
No Intervention: Normal care; Normal care without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Vanessa ZINZONI, vanessa.zinzoni@ght85.fr

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pelvic Neoplasms
• Other Study ID Numbers: CHD22_0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No