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Not yet recruiting NCT06589739

Chest Drain Insertion Assisted by Virtual Reality

No phase Interventional Pneumothorax Spontaneous Primary Pneumothorax Spontaneous Secondary Pleural Effusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Headset.
Who it may be relevant to
Registry conditions: Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary, Pleural Effusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle

Overview

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

Interventions

  • Device Virtual Reality Headset
    A virtual reality headset will be placed on patients\' head before and during chest drain insertion

Primary outcome measures

  • Pain - Chest drain [Time frame: During chest drain insertion]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 37854306

Identifiers

NCT: NCT06589739 · 2024-A01192-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗