ClinicalTrials.gg
Not yet recruitingNCT06589739CASVIAUpdated Sep 19, 2024

Chest Drain Insertion Assisted by Virtual Reality

An interventional study of Virtual Reality Headset in Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary and Pleural Effusion, sponsored by Central Hospital, Nancy, France. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Pneumothorax Spontaneous Primary
  • Pneumothorax Spontaneous Secondary
  • Pleural Effusion

Keywords

  • virtual reality
  • chest drain
  • pain management
  • chest tube
  • anxiety management
03

In context

Pneumothorax

183 studies on the registry are indexed under Pneumothorax; 41 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 111 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    virtual reality headset

    Patients in this arm will have a reality helmet placed during chest drain insertion

    Device: Virtual Reality Headset

  • No intervention
    control group

Interventions

  • DeviceVirtual Reality Headset

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

06

What researchers measure

Primary outcomes

  1. Pain - Chest drain

    Visual Analogic Scale

    Time frame: During chest drain insertion

Secondary outcomes

  1. Pain - Antalgic consumption

    Antalgic consumption

    Time frame: during the 24 hours after chest drain insertion

  2. Pain - 30 minutes

    Visual Analogic scale

    Time frame: 30 minutes after chest drain insertion

  3. Anxiety - Chest drain

    Anxiety Visual Analogic Scale

    Time frame: During chest drain insertion

  4. Anxiety - 30 minutes

    Anxiety Visual Analogic Scale

    Time frame: 30 minutes after chest drain insertion

  5. feasibility

    Was the chest drain insertion duable with the virtual reality headset

    Time frame: During chest drain insertion

07

Study locations

No study locations are listed for this record.

08

References and documents

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 29485536 ↗
  • Perenic 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589739
Responsible party
STREIT Arthur (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Arthur Streit, MD, MSc
Contact
a.streit@chru-nancy.fr
+33 383153365
Joseph Seitlinger, MD, Phd
Contact
j.seitlinger@chru-nancy.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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