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RecruitingNCT06799806REVAUpdated Mar 24, 2025

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

An interventional study of virtual reality device in Bronchial Fibroscopy, sponsored by Centre Hospitalier le Mans. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bronchial Fibroscopy

Keywords

  • virtual reality headset
  • anxiety
03

In context

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 42 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    virtual reality

    virtual reality headset

    Device: virtual reality device

Interventions

  • Devicevirtual reality device

    20 minutes session with virtual reality device

06

What researchers measure

Primary outcomes

  1. Anxiety assessment

    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.

    Time frame: Immediately after intervention

Secondary outcomes

  1. Assessment of bronchoscopy realisation and sample collection

    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.

    Time frame: Immediately after intervention

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Le Mans
    Le Mans, 72000, France
    • Christelle JADEAU, MD · Contact · cjadeau@ch-lemans.fr · +332 44 71 07 81
    • Christine PETIT · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06799806
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Jan 29, 2025
Start date
Feb 27, 2025
Primary completion
Feb 27, 2026 (estimated)
Completion
Feb 27, 2026 (estimated)
Last update
Mar 24, 2025

Study contacts

Christelle JADEAU
Contact
cjadeau@ch-lemans.fr
+332 44 71 07 81
Christine PETIT
principal investigator · Centre Hospitalier le Mans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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