Status:
NOT_YET_RECRUITING
Chest Drain Insertion Assisted by Virtual Reality
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Pneumothorax Spontaneous Primary
Pneumothorax Spontaneous Secondary
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06589739
Start Date
October 1 2024
End Date
October 1 2025
Last Update
September 19 2024
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