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OpenTrials
Completed

NCT Number: NCT05966402

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

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.

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Key information

Conditions

Interventional Imaging

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAEN University Hospital

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual Reality

Other

Immersion in Virtual Reality

Primary outcomes

  1. anxiety measured with STAI Y-B

    Time frame: once (as close as possible to the interventional gesture, i.e. just after it.)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: IRVARI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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