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

NCT06799806 | Recruiting

• 1 other identifier: CHM-2024/S15/04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchial Fibroscopy

Keywords

virtual reality headset; anxiety

Outcome Measures

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.

  Immediately after intervention

Secondary Outcomes (1)

• Assessment of bronchoscopy realisation and sample collection

  Immediately after intervention

Study Arms (1)

virtual reality

EXPERIMENTAL

virtual reality headset

Device: virtual reality device

Interventions

virtual reality device DEVICE

20 minutes session with virtual reality device

virtual reality

Eligibility Criteria

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

You may qualify if:

• 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 .
• Patient able and willing to answer questionnaires

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Christine PETIT

  Centre Hospitalier le Mans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle JADEAU

CONTACT

+332 44 71 07 81; cjadeau@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, prospective, interventional study

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 29, 2025
• Study Start: February 27, 2025
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)