Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.

Interventional Imaging Clinical Trial

— IRVARI  

Official title:

Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966402
• Other study ID #: 19-197
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: July 19, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside…) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room. Hypothesis tested: The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an interventional radiology intervention would reduce the anxiety felt by patients by 25%, evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD scales will also be tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients (18-80 years old) with an indication for performing one of the following interventional radiology procedures, according to HAS recommendations: Liver biopsy puncture, embolization of varicoceles, embolization of pelvic varices, embolization of uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma, radioembolization.

Exclusion Criteria:

• Pregnant or breastfeeding women.
• Minor or age > 80 years.
• People suffering from psychiatric pathologies, chronic depressive syndrome or chronic anxiety disorder.
• People with a high risk of motion sickness during virtual reality immersion (MMSQ and VIMSSQ > 80th percentile).

Related Conditions & MeSH terms

• Interventional Imaging

Intervention

Other:
• Virtual Reality
Immersion in Virtual Reality

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety measured with STAI Y-B	For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.	once (as close as possible to the interventional gesture, i.e. just after it.)