Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:
NCT ID: NCT06691438
Last Updated: 2024-11-15
Study Results
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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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-12-01
2026-10-01
Brief Summary
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Detailed Description
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Patients will be randomized on the same day of the procedure into one of the two study groups.
A single follow-up visit will be performed postoperatively 1 month after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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prostate biopsies without virtual reality hypnosis headset
Biopsies are performed according to current recommendations
prostate biopsy
prostate biopsies with virtual reality hypnosis headset
prostate biopsies with virtual reality hypnosis headset
Patient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure.
prostate biopsy
prostate biopsies with virtual reality hypnosis headset
Interventions
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prostate biopsy
prostate biopsies with virtual reality hypnosis headset
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient having signed informed consent
Exclusion Criteria
* Deaf or hard of hearing patients
* Patients suffering from epilepsy and/or mental deficiency, and/or disorders of higher functions
* Psychotic patients
* Claustrophobic patients or those who cannot tolerate a mask over their eyes
* Refusal of local anesthesia
* Protected person (art. L1121-5 to L1121-8 of the CSP)
18 Years
MALE
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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EssaiClinique_HYPNOSURG-VR
Professeur
Principal Investigators
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Gaelle GF FIARD, professor
Role: PRINCIPAL_INVESTIGATOR
university grenoble hospital
Locations
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University Hospital Grenoble
Grenoble, , France
Countries
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Central Contacts
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Other Identifiers
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EssaiClinique_HYPNOSURG-VR
Identifier Type: -
Identifier Source: org_study_id
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