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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)

C

Centre Hospitalier Universitaire de Nice

Status

Active, not recruiting

Conditions

Pneumothorax
Pleural Effusion
Drainage of Liquor

Treatments

Device: Drainage with Headset Hypno VR

Study type

Interventional

Funder types

Other

Identifiers

NCT07206940
24-AOI-01

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

Reality virtual
Experimental group
Description:
Standard support with reality virtual headset
Treatment:
Device: Drainage with Headset Hypno VR
Standard of care
No Intervention group
Description:
Standard support without reality virtual headset

Trial contacts and locations

1

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Central trial contact

Nelly BANSE

Data sourced from clinicaltrials.gov

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