PneumothoraxeSEDATIONNCT07206940
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
A study testing Drainage with Headset Hypno VR in people with Pneumothorax and Pleural Effusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Pleural Effusion, Drainage of Liquor
- What is being tested?
- Drainage with Headset Hypno VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pneumothorax, Pleural Effusion, Drainage of Liquor
- Being tested
- Drainage with Headset Hypno VR
- Keywords
- Pneumothorax, Pleural Effusion, Drainage, virtual reality, anxiety reduction
- Medical subject headings
- Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage with Headset Hypno VRDevice
Pleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset.
| Study group | Role | What they receive |
|---|---|---|
| Reality virtual | Experimental | Standard support with reality virtual headset Receives: Device: Drainage with Headset Hypno VR |
| Standard of care | No intervention | Standard support without reality virtual headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start27 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly BANSE, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206940
- Sponsor's protocol ID
- 24-AOI-01
- Acronym
- eSEDATION
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07206940
- Acronym / sponsor ID
- eSEDATION / 24-AOI-01
- Conditions
- Pneumothorax, Pleural Effusion, Drainage of Liquor
- Keywords
- Pneumothorax, Pleural Effusion, Drainage, virtual reality, anxiety reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reality virtual | Experimental | Device: Drainage with Headset Hypno VRStandard support with reality virtual headset |
| Standard of care | No intervention | –Standard support without reality virtual headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drainage with Headset Hypno VRPleural effusion and pneumothorax will be drained with the patient wearing the virtual reality headset. | Device | Reality virtual |
Primary outcome
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.
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.
4 secondary outcomes
Pain assessment with or without VR headset based on heart rate
Time frame: 18 months
Pain assessment with or without VR headset based on respiratory rate
Time frame: 18 months
Patient satisfaction
Time frame: 18 months
Satisfaction of the paramedical team
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly BANSE principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drainage with Headset Hypno VR in people with Pneumothorax and Pleural Effusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Effects of personalized virtual reality (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.