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

NCT06691438 | Not Yet Recruiting

• 1 other identifier: EssaiClinique_HYPNOSURG-VR
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Biopsy

Keywords

Sedation; Pain; Hypnosis; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• To prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset.

  maximum pain felt during the procedure on a numerical EN scale, ranging from 0 (no pain) to 10 (extreme pain). The values will be collected directly at the end of the procedure.

  after the procedure

Secondary Outcomes (12)

• Pain after the procedure

  when leaving the hospital

• Stress during the procedure

  after the procedure

• Immersion during hypnosis

  at the procedure

• Evaluation of the nociceptive response to painful stimuli

  during the procedure

• Satisfaction with the procedure

  after the procedure

Study Arms (2)

prostate biopsies without virtual reality hypnosis headset

ACTIVE COMPARATOR

Biopsies are performed according to current recommendations

Device: prostate biopsy

prostate biopsies with virtual reality hypnosis headset

EXPERIMENTAL

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

Device: prostate biopsy

Interventions

prostate biopsy DEVICE

prostate biopsies with virtual reality hypnosis headset

Also known as: experimental

prostate biopsies with virtual reality hypnosis headset; prostate biopsies without virtual reality hypnosis headset

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaelle GF FIARD, professor

  university grenoble hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaelle GF FIARD, Professor

CONTACT

0476767642; gfiard@chu-grenoble.fr

Assilah AB BOUZIT, study co

CONTACT

0476767971; abouzit@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The maximum value of the pain will be collected by the research associate or the coordinating nurse who will be blinded to the randomization arm
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 15, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)