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NCT Number: NCT06589739

Chest Drain Insertion Assisted by Virtual Reality

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset

Device

A virtual reality headset will be placed on patients' head before and during chest drain insertion

Primary outcomes

  1. Pain - Chest drain

    Time frame: During chest drain insertion

    Visual Analogic Scale

Secondary outcomes

  1. Pain - Antalgic consumption

    Time frame: during the 24 hours after chest drain insertion

    Antalgic consumption

  2. Pain - 30 minutes

    Time frame: 30 minutes after chest drain insertion

    Visual Analogic scale

  3. Anxiety - Chest drain

    Time frame: During chest drain insertion

    Anxiety Visual Analogic Scale

  4. Anxiety - 30 minutes

    Time frame: 30 minutes after chest drain insertion

    Anxiety Visual Analogic Scale

  5. feasibility

    Time frame: During chest drain insertion

    Was the chest drain insertion duable with the virtual reality headset

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur Streit, MD, MSc

CONTACT

[email protected]

+33 383153365

Joseph Seitlinger, MD, Phd

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle

Acronym: CASVIA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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