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 — Not applicable, Active not recruiting, 38 participants, Centre Hospitalier Universitaire de Nice

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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 - eSEDATION

Registry	NCT07206940, acronym eSEDATION
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	38 (Estimated)
Sponsor	Centre Hospitalier Universitaire de Nice (Other)
Conditions	Pneumothorax, Pleural Effusion, Drainage of Liquor
Interventions	Drainage with Headset Hypno VR (Device)
Dates	start 2025-11-27, primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2025-10-03, last updated 2025-12-31
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Reality virtual	Experimental	Device: Drainage with Headset Hypno VR	Standard support with reality virtual headset
Standard of care	No intervention		Standard support without reality virtual headset

Drainage with Headset Hypno VR (Device): Pleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
CHU Nice - Hôpital Pasteur 2	Nice, Alpes-Maritimes	France

+Investigators

Nelly BANSE, Principal investigator, Centre Hospitalier Universitaire de Nice