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OpenTrials
Completed

NCT Number: NCT05269186

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

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.

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Key information

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHD Vendée

La Roche-sur-Yon, 85000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Patient participating in another clinical investigation or interventional clinical research protocol involving a drug
  • Pregnant or breastfeeding patient

Treatment and study plan

Virtual reality software

Device

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

Primary outcomes

  1. Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management

    Time frame: 10 minute before the planning CT scan

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: REAVA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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