Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia: (HYPNOSURG-VR)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Prostate Biopsy

Treatments: Device: prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06691438

EssaiClinique_HYPNOSURG-VR

Details and patient eligibility

About

The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.

Full description

Prospective comparison of pain during the procedure assessed in patients treated for prostate biopsies under local anesthesia with or without a virtual reality headset.No additional examination will be performed in addition to the conventional management of a biopsy except for the fitting of the headset for patients randomized to the "with virtual reality headset" group.

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.

Enrollment: 130 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
• Patient having signed informed consent

Exclusion criteria

• Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset
• 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

prostate biopsies without virtual reality hypnosis headset

Active Comparator group

Description:

Biopsies are performed according to current recommendations

Treatment:

Device: prostate biopsy

prostate biopsies with virtual reality hypnosis headset

Experimental group

Description:

Patient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure.

Treatment:

Device: prostate biopsy