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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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07206940
Acronym
eSEDATION
Enrollment
38
Registered
2025-10-03
Start date
2025-11-27
Completion date
2027-05-31
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drainage of Liquor, Pleural Effusion, Pneumothorax

Keywords

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

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.

Interventions

DEVICEDrainage with Headset Hypno VR

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain and Effects of personalized virtual reality18 monthsCompare 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 reality18 monthsCompare 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

MeasureTime frameDescription
Pain assessment with or without VR headset based on heart rate18 monthsHeart 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 rate18 monthsRespiratory rate will be used to assess the patient's pain. A respiratory rate of 12 to 20 cycles per minute is normal.
Patient satisfaction18 monthsThe 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 team18 monthsThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026