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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Pain and Effects of personalized virtual reality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of care
Standard support without reality virtual headset
Reality virtual
Standard support with reality virtual headset
Intervention: Drainage with Headset Hypno VR (Device)
Outcomes
Primary Outcomes
Pain and Effects of personalized virtual reality
Time Frame: 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
Time Frame: 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 Outcomes
- 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)