Clinical trial NCT06589739: Chest Drain Insertion Assisted by Virtual Reality
Official title: Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pneumothorax Spontaneous Primary
Pneumothorax Spontaneous Secondary
Pleural Effusion
Keywords: virtual reality
chest drain
pain management
chest tube
anxiety management
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39; pain and anxiety


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

Primary outcomes:
measure: Pain - Chest drain
timeFrame: During chest drain insertion
Secondary outcomes:
measure: Pain - Antalgic consumption
timeFrame: during the 24 hours after chest drain insertion
measure: Pain - 30 minutes
timeFrame: 30 minutes after chest drain insertion
measure: Anxiety - Chest drain
timeFrame: During chest drain insertion
measure: Anxiety - 30 minutes
timeFrame: 30 minutes after chest drain insertion
measure: feasibility
timeFrame: During chest drain insertion
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.