Chest Drain Insertion Assisted by Virtual Reality

NCT06589739 | Not Yet Recruiting

• 1 other identifier: 2024-A01192-45
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pneumothorax Spontaneous Primary; Pneumothorax Spontaneous Secondary; Pleural Effusion

Keywords

virtual reality; chest drain; pain management; chest tube; anxiety management

Outcome Measures

Primary Outcomes (1)

• Pain - Chest drain

  Visual Analogic Scale

  During chest drain insertion

Secondary Outcomes (5)

• Pain - Antalgic consumption

  during the 24 hours after chest drain insertion

• Pain - 30 minutes

  30 minutes after chest drain insertion

• Anxiety - Chest drain

  During chest drain insertion

• Anxiety - 30 minutes

  30 minutes after chest drain insertion

• feasibility

  During chest drain insertion

Study Arms (2)

virtual reality headset

EXPERIMENTAL

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

Device: Virtual Reality Headset

control group

NO INTERVENTION

Interventions

Virtual Reality Headset DEVICE

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

virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Pleural Effusion; Agnosia

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arthur Streit, MD, MSc

CONTACT

+33 383153365; a.streit@chru-nancy.fr

Joseph Seitlinger, MD, Phd

CONTACT

j.seitlinger@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share