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Clinical Trial NCT07206940 (eSEDATION) for Pneumothorax, Pleural Effusion, Drainage of Liquor is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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)

Not yet recruiting
Clinical Trial NCT07206940 (eSEDATION) is an interventional study for Pneumothorax, Pleural Effusion, Drainage of Liquor is not yet recruiting. Enrollment is planned to begin on 1 November 2025 until the trial accrues 38 participants. Led by Centre Hospitalier Universitaire de Nice, this trial is expected to complete by 1 May 2027. The latest data from ClinicalTrials.gov was last updated on 3 October 2025.
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.
Official Title

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

Conditions
PneumothoraxPleural EffusionDrainage of Liquor
Other Study IDs
  • eSEDATION
  • 24-AOI-01
NCT ID Number
NCT07206940
Start Date (Actual)
2025-11
Last Update Posted
2025-10-03
Completion Date (Estimated)
2027-05
Enrollment (Estimated)
38
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Pneumothorax
Pleural Effusion
Drainage
virtual reality
anxiety reduction
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalReality virtual
Standard support with reality virtual headset
Drainage with Headset HYPNO VR
Pleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset.
No InterventionStandard of care
Standard support without reality virtual headset
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Centre Hospitalier Universitaire de Nice logoCentre Hospitalier Universitaire de Nice
Study Central Contact
Contact: Nelly BANSE, 4 92 03 80 52, [email protected]
1 Study Locations in 1 Countries

Alpes-Maritimes

CHU Nice - Hôpital Pasteur 2, Nice, Alpes-Maritimes, 06000, France
Nelly BANSE, Contact, 4 92 03 80 52, [email protected]