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NCT Number: NCT07206940

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pneumothorax Drainage of Liquor Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drainage with Headset Hypno VR

Device

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

Primary outcomes

  1. 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.

  2. 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

  1. Pain assessment with or without VR headset based on heart rate

    Time frame: 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.

  2. Pain assessment with or without VR headset based on respiratory rate

    Time frame: 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.

  3. Patient satisfaction

    Time frame: 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.

  4. Satisfaction of the paramedical team

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: eSEDATION

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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