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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchial Fibroscopy
• Intervention / Treatment: Device: virtual reality device

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +332 44 71 07 81; Email: cjadeau@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier Le Mans
    • Contact: Christelle JADEAU, MD; Phone Number: +332 44 71 07 81; Email: cjadeau@ch-lemans.fr
    • Contact: Christine PETIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; virtual reality headset	Device: virtual reality device; 20 minutes session with virtual reality device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after intervention

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Christine PETIT, Centre Hospitalier Le Mans

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): February 27, 2026
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; virtual reality headset
• Other Study ID Numbers: CHM-2024/S15/04

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
• product manufactured in and exported from the U.S.: No