Study of the Benefits of Virtual Reality Headsets for Reducing Anxiety in Patients Treated for Pleural Effusion or Pneumothorax Using Small-bore Chest Drainage Tubes

NCT07206940 | Active Not Recruiting

• 1 other identifier: 24-AOI-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Pleural effusion and pneumothorax are common conditions encountered in pulmonology departments and may require chest drainage. However, the chest drainage procedure can cause anxiety in patients, leading to discomfort during the procedure. The use of virtual reality (VR) for anxiety reduction has shown promising results in various medical contexts.

Conditions

Pleural Effusion; Pneumothorax; Drainage of Liquor

Keywords

Pneumothorax; Pleural Effusion; Drainage; virtual reality; anxiety reduction

Outcome Measures

Primary Outcomes (2)

• Pain and Effects of personalized virtual reality

  Compare the effects of personalized virtual reality support, compared to standard support, on pain in patients undergoing chest drainage with numerical pain scale from 0 to 10.

  18 months

• Anxiety and Effects of personalized virtual reality

  Compare the effects of personalized virtual reality support, compared to standard support, on anxiety in patients undergoing chest drainage with numerical anxiety scale from 0 to 10.

  18 months

Secondary Outcomes (4)

• Pain assessment with or without VR headset based on heart rate

  18 months

• Pain assessment with or without VR headset based on respiratory rate

  18 months

• Patient satisfaction

  18 months

• Satisfaction of the paramedical team

  18 months

Study Arms (2)

Reality virtual

EXPERIMENTAL

Standard support with reality virtual headset

Device: Drainage with Headset Hypno VR

Standard of care

NO INTERVENTION

Standard support without reality virtual headset

Interventions

Drainage with Headset Hypno VR DEVICE

Pleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset.

Reality virtual

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Patient requiring Sledinger thoracic drainage for pneumothorax or pleural effusion in the pulmonology department of Nice University Hospital;
• Patient affiliated with social security;
• Signature of informed consent.

You may not qualify if:

• Immediate emergency situations;
• Anxiolytic, antidepressant, or psychotropic treatment already in place;
• Cognitive, behavioral, or psychiatric disorders;
• Language barrier;
• History of chest drainage or chest surgery;
• Hearing disorders without hearing aids;
• Vision disorders without corrective lenses (lack of binocular vision, blindness);
• Psychotic patients or patients diagnosed with psychiatric disorders;
• History of epilepsy;
• Current migraine;
• Patients for whom three-dimensional films are contraindicated (pacemaker or defibrillator);
• No social security coverage;
• Patients under guardianship/curatorship.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

Location

MeSH Terms

Conditions

Pneumothorax; Pleural Effusion

Interventions

Drainage

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Nelly BANSE

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)