NCT05966402

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

July 20, 2023

Last Update Submit

July 27, 2023

Conditions

Interventional Imaging

Outcome Measures

Primary Outcomes (1)

  • 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.)

Study Arms (2)

Virtual Reality

EXPERIMENTAL
Other: Virtual Reality

standard care

NO INTERVENTION

Interventions

Virtual RealityOTHER

Immersion in Virtual Reality

Virtual Reality

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAEN University Hospital

Caen, 14033, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

July 28, 2023

Study Start

May 17, 2021

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)