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

NCT05269186 | Completed

• 1 other identifier: CHD22_0002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Virtual reality

EXPERIMENTAL

Virtual reality session performed before the planning CT scan

Device: Virtual reality software

Normal care

NO INTERVENTION

Normal care without intervention

Interventions

Virtual reality software DEVICE

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

Virtual reality

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix)
• Patient ≥ 18 years old,
• Patient who has the capacity to understand the protocol and has given written consent to participate in the research,
• Patient with social security coverage.

You may not qualify if:

• Metastatic patients
• Patients with previous radiotherapy
• Patients with a diagnosis of hearing impairment
• Patients with major cognitive disorders (such as dementia)
• Psychiatric pathology such as schizophrenia
• Patients with epilepsy or hypersensitivity to flashing lights
• Patient with a pacemaker, hearing aid or defibrillator
• Claustrophobic patients
• Patients sensitive to motion sickness
• Patients who are visually impaired or blind
• Patients with migraine
• Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes
• Patients under guardianship, curators or deprived of liberty
• Non French speaking patient
• Illiterate patient

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vanessa ZINZONI

  vanessa.zinzoni@ght85.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: October 5, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)