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NCT Number: NCT06799806

The Impact of the Therapeutic Virtual Reality Headset on Patient Anxiety in the Waiting Room Before Flexible Bronchoscopy in Vigil

Bronchial fibroscopy is a frequently used procedure in the management of pneumology patients, and can be a source of anxiety, particularly while waiting for the examination.

Investigator's professional experience has shown us that many patients are anxious in the waiting room before a flexible bronchoscopy in vigile.

A great deal of research has been carried out into the use of virtual reality to reduce anxiety and pain during care but shortly before bronchoscopy. The innovative aspect is to target the patient's waiting time for the examination. Waiting is a highly anxiety-provoking time, and nurses play a vital role in supporting patients.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Le Mans

Le Mans, 72000, France

Location status: Recruiting

Location contact

Christelle JADEAU, MD

CONTACT

[email protected]

+332 44 71 07 81

Christine PETIT

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with no age or gender restrictions, seen on an outpatient basis at Le Mans Hospital.
  • In whom bronchial fibroscopy is indicated.
  • Person affiliated with or benefiting from a social security .
  • Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
  • Patient able and willing to answer questionnaires

Exclusion criteria

  • Patient refusing to participate in research
  • Patient who has already undergone bronchoscopy in vigil
  • Patient premedicated for bronchial fibroscopy (anxiolytic, etc.)
  • Patients with a history of epilepsy or psychiatric pathology
  • Patient with vertigo
  • Patient uncooperative, demented or unable to tolerate headgear.
  • patient under guardianship or curatorship
  • Patients suffering from blindness or deafness
  • Patient with known significant intolerance to screens and/or virtual reality devices
  • Pregnant, nursing or parturient women
  • Unscheduled patients: emergencies, etc.
  • Hospitalized patients

Treatment and study plan

Virtual Reality Device

Device

20 minutes session with virtual reality device

Primary outcomes

  1. Anxiety assessment

    Time frame: Immediately after intervention

    Anxiety assessment is measured using a Numerical Rating Scale (NRS) from 0 to 10, supplemented by a self-assessment questionnaire before and after using the Therapeutic Virtual Reality Headset.

Secondary outcomes

  1. Assessment of bronchoscopy realisation and sample collection

    Time frame: Immediately after intervention

    Assessment of whether bronchoscopy has been performed correctly in the vigile state, aas well as any sampling required, using a questionnaire completed by the nurse present during vigile flexible bronchoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

+332 44 71 07 81

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: REVA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Mar 24, 2025

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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