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 (eSEDATION)

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 - eSEDATION

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumothorax; Pleural Effusion; Drainage of Liquor
• Intervention / Treatment: Device: Drainage with Headset Hypno VR

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06000
      • CHU Nice - Hôpital Pasteur 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reality virtual; Standard support with reality virtual headset	Device: Drainage with Headset Hypno VR; Pleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset.
No Intervention: Standard of care; Standard support without reality virtual headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment with or without VR headset based on heart rate	Heart rate will be used to assess the patient's pain. A heart rate between 55 and 85 beats per minute is normal.	18 months
Pain assessment with or without VR headset based on respiratory rate	Respiratory rate will be used to assess the patient's pain. A respiratory rate of 12 to 20 cycles per minute is normal.	18 months
Patient satisfaction	The evaluation will be based on the following question asked to the patient: "Are you satisfied overall with how the procedure went?" Possible answers: Yes/No.	18 months
Satisfaction of the paramedical team	The evaluation will be based on the following question asked to the paramedical team: "Are you generally satisfied with how the intervention went?" Possible answers: Yes/No	18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Nelly BANSE, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: September 26, 2025
• First Posted (Estimated): October 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Drainage; virtual reality; Pneumothorax; Pleural Effusion; anxiety reduction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Pneumothorax; Therapeutics; Surgical Procedures, Operative; Drainage
• Other Study ID Numbers: 24-AOI-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No