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

NCT ID: NCT05966402

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2023-07-19

Brief Summary

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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.

Detailed Description

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Conditions

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Interventional Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Virtual Reality

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type OTHER

Immersion in Virtual Reality

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

Immersion in Virtual Reality

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CAEN University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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19-197

Identifier Type: -

Identifier Source: org_study_id