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)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Biopsy
• Intervention / Treatment: Device: prostate biopsy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaelle GF FIARD, Professor; Phone Number: +33 0476767642; Email: gfiard@chu-grenoble.fr
• Study Contact Backup: Name: assilah AB BOUZIT, study co; Phone Number: +33 0476767971; Email: abouzit@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38043
    • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prostate biopsies without virtual reality hypnosis headset; Biopsies are performed according to current recommendations	Device: prostate biopsy; prostate biopsies with virtual reality hypnosis headset; Other Names: experimental
Experimental: 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.	Device: prostate biopsy; prostate biopsies with virtual reality hypnosis headset; Other Names: experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after the procedure	Numerical scale 0-10 of pain upon discharge from the hospital	when leaving the hospital
Stress during the procedure	Numerical stress scale from 0 to 10 upon arrival of the patient, and 15 minutes after the procedure	after the procedure
Immersion during hypnosis	Immersion scale from 0 to 10 during hypnosis	at the procedure
Evaluation of the nociceptive response to painful stimuli	Heart rate variability (= HRV) on the ECG trace (in milliseconds)	during the procedure
Satisfaction with the procedure	Desire to repeat this method of anesthesia in the event of an iterative procedure versus general anesthesia (yes/no)	after the procedure
Duration of the procedure	Duration of the procedure in minutes (time between the start of the procedure and the end of the procedure by the surgeon)	after the procedure
Length of stay in hospital / outpatient care	Length of stay in day hospital or outpatient care, in minutes (Time leaving the room - Time entering the room)	at 1 month
Success of biopsies	Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no)	at 1 month
Need for general anesthesia	Rate of need for general anesthesia (in %)	after the procedure
Pain upon returning home the same evening and on D1	Numerical pain scale 0-10 on returning home the same evening and on D1 collected in the patient notebook	after procedure, at 1 day after procedure
Adverse effects related to the procedure during one month	Patient notebook for collecting adverse effects for 1 month	at 1 month
Qualitative assessment of the patient's experience	Semi-directed interview directly after the procedure	after the procedure

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Gaelle GF FIARD, professor, university grenoble hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Hypnosis; Virtual Reality; Sedation
• Other Study ID Numbers: EssaiClinique_HYPNOSURG-VR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No