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

Not Applicable

Not yet recruiting

• Conditions: Pneumothorax; Pleural Effusion; Drainage of Liquor

• Registration Number: NCT07206940
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2027-05
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain and Effects of personalized virtual reality	18 months	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.
Anxiety and Effects of personalized virtual reality	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain assessment with or without VR headset based on heart rate	18 months	Heart rate will be used to assess the patient's pain. A heart rate between 55 and 85 beats per minute is normal.
Pain assessment with or without VR headset based on respiratory rate	18 months	Respiratory rate will be used to assess the patient's pain. A respiratory rate of 12 to 20 cycles per minute is normal.
Patient satisfaction	18 months	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.
Satisfaction of the paramedical team	18 months	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

Trial Locations

Locations (1)

CHU Nice - Hôpital Pasteur 2; 🇫🇷 Nice, Alpes-Maritimes, France