Chest Drain Insertion Assisted by Virtual Reality

Not Applicable

Not yet recruiting

• Conditions: Pneumothorax Spontaneous Primary; Pneumothorax Spontaneous Secondary; Pleural Effusion

• Registration Number: NCT06589739
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-10-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain - Chest drain	During chest drain insertion	Visual Analogic Scale

Secondary Outcome Measures

Name	Time	Method
Pain - Antalgic consumption	during the 24 hours after chest drain insertion	Antalgic consumption
Pain - 30 minutes	30 minutes after chest drain insertion	Visual Analogic scale
Anxiety - Chest drain	During chest drain insertion	Anxiety Visual Analogic Scale
Anxiety - 30 minutes	30 minutes after chest drain insertion	Anxiety Visual Analogic Scale
feasibility	During chest drain insertion	Was the chest drain insertion duable with the virtual reality headset