Pneumothorax Spontaneous PrimaryCASVIANCT06589739
Chest Drain Insertion Assisted by Virtual Reality
A study testing Virtual Reality Headset in people with Pneumothorax Spontaneous Primary and Pneumothorax Spontaneous Secondary, run by Central Hospital, Nancy, France.
Trial summary
Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\' pain and anxiety Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Indication of chest drain insertion for pleural effusion or primary spontaneous pneumothorax
- Patient who received clear and loyal information abotu the study protocol
- Patient who consented to participate to the study
- Patient aged 18 years old or older
- Patient affiliated to the french health system
Who cannot join
- Patient aged less than 18 years old
- Patient in emergency situation
- Patient with severe heart condition
- Patient allergic to silicone
- Patient with severe psychiatric or mental disorder
- patient with binocular vision anomaly
Show all 18Show fewer
- patient with pacemaker or defibrillator
- patient wearing a hearing aid that cannot be removed
- Patients under the influence of alcohol or drugs, nausea, fatigue, emotional or anxiety disorders, migraine, headaches, infectious disease
- Patient with past medical history of epilepsia or convulsion
- -- Persons covered by articles L. 1121-5 and L1121-8 of the French Public Health Code:
- Pregnant, parturient or breast-feeding women,
- Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- adults unable to give their consent
- Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
- Person able to give consent but unable to write
- Person able to give consent but unable to read French
- Patient unable to consent to the study
Trial locations and contacts
No sites are listed yet.
Joseph Seitlinger, MD, Phd contact
About this study
Official title: Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle
Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\' pain and anxiety
- Being tested
- Virtual Reality Headset
- Keywords
- virtual reality, chest drain, pain management, chest tube, anxiety management
- Medical subject headings
- Pneumothorax, Pleural Effusion, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
A virtual reality headset will be placed on patients\' head before and during chest drain insertion
| Study group | Role | What they receive |
|---|---|---|
| virtual reality headset | Experimental | Patients in this arm will have a reality helmet placed during chest drain insertion Receives: Device: Virtual Reality Headset |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Chest drain
Visual Analogic Scale
Measured: During chest drain insertion
Secondary outcomes (5)
Pain - Antalgic consumption
Antalgic consumption
Measured: during the 24 hours after chest drain insertion
Pain - 30 minutes
Visual Analogic scale
Measured: 30 minutes after chest drain insertion
Anxiety - Chest drain
Anxiety Visual Analogic Scale
Measured: During chest drain insertion
Anxiety - 30 minutes
Anxiety Visual Analogic Scale
Measured: 30 minutes after chest drain insertion
feasibility
Was the chest drain insertion duable with the virtual reality headset
Measured: During chest drain insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumothorax Spontaneous PrimaryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STREIT Arthur, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589739
- Sponsor's protocol ID
- 2024-A01192-45
- Acronym
- CASVIA
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
PubMed 29485536Perenic E, Grember E, Bassard S, Koutlidis N. Impact of virtual reality on pain management in transrectal MRI-guided prostate biopsy. Front Pain Res (Lausanne). 2023 Oct 2;4:1156463. doi: 10.3389/fpain.2023.1156463. eCollection 2023.
PubMed 37854306
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle
- ClinicalTrials.gov ID
- NCT06589739
- Acronym / sponsor ID
- CASVIA / 2024-A01192-45
- Keywords
- virtual reality, chest drain, pain management, chest tube, anxiety management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\' pain and anxiety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality headset | Experimental | Device: Virtual Reality HeadsetPatients in this arm will have a reality helmet placed during chest drain insertion |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indication of chest drain insertion for pleural effusion or primary spontaneous pneumothorax
- Patient who received clear and loyal information abotu the study protocol
- Patient who consented to participate to the study
- Patient aged 18 years old or older
- Patient affiliated to the french health system
Key exclusion criteria (18 listed)
- Patient aged less than 18 years old
- Patient in emergency situation
- Patient with severe heart condition
- Patient allergic to silicone
- Patient with severe psychiatric or mental disorder
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 |
|---|---|---|
| Virtual Reality HeadsetA virtual reality headset will be placed on patients\' head before and during chest drain insertion | Device | virtual reality headset |
Primary outcome
Pain - Chest drain
Time frame: During chest drain insertion
Visual Analogic Scale
5 secondary outcomes
Pain - Antalgic consumption
Time frame: during the 24 hours after chest drain insertion
Pain - 30 minutes
Time frame: 30 minutes after chest drain insertion
Anxiety - Chest drain
Time frame: During chest drain insertion
Anxiety - 30 minutes
Time frame: 30 minutes after chest drain insertion
feasibility
Time frame: During chest drain insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29485536Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
- Background: PubMed 37854306Perenic E, Grember E, Bassard S, Koutlidis N. Impact of virtual reality on pain management in transrectal MRI-guided prostate biopsy. Front Pain Res (Lausanne). 2023 Oct 2;4:1156463. doi: 10.3389/fpain.2023.1156463. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Joseph Seitlinger, MD, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with Pneumothorax Spontaneous Primary and Pneumothorax Spontaneous Secondary, run by Central Hospital, Nancy, 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur Streit, MD, MSc (+33 383153365, a.streit@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Chest drain (time frame: During chest drain insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589739, which also lists 2 linked publications.
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 19 Sep 2024.