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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) logo

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

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

Trial contacts and locations

1

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Central trial contact

Assilah AB BOUZIT, study co; Gaelle GF FIARD, Professor

Data sourced from clinicaltrials.gov

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