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Chest Drain Insertion Assisted by Virtual Reality (CASVIA)

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Pleural Effusion
Pneumothorax Spontaneous Secondary
Pneumothorax Spontaneous Primary

Treatments

Device: Virtual Reality Headset

Study type

Interventional

Funder types

Other

Identifiers

NCT06589739
2024-A01192-45

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

virtual reality headset
Experimental group
Description:
Patients in this arm will have a reality helmet placed during chest drain insertion
Treatment:
Device: Virtual Reality Headset
control group
No Intervention group

Trial contacts and locations

0

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Central trial contact

Joseph Seitlinger, MD, Phd; Arthur Streit, MD, MSc

Data sourced from clinicaltrials.gov

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