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

NCT ID: NCT07206940

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-27

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumothorax Pleural Effusion Drainage of Liquor

Keywords

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Pneumothorax Pleural Effusion Drainage virtual reality anxiety reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Reality virtual

Standard support with reality virtual headset

Group Type EXPERIMENTAL

Drainage with Headset Hypno VR

Intervention Type DEVICE

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

Standard of care

Standard support without reality virtual headset

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Drainage with Headset Hypno VR

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nelly BANSE

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU Nice - Hôpital Pasteur 2

Nice, Alpes-Maritimes, France

Site Status

Countries

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France

Other Identifiers

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24-AOI-01

Identifier Type: -

Identifier Source: org_study_id