Clinical trial NCT06691438: Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Biopsy
Keywords: Sedation
Pain
Hypnosis
Virtual Reality
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: after the procedure
Secondary outcomes:
measure: Pain after the procedure
timeFrame: when leaving the hospital
measure: Stress during the procedure
timeFrame: after the procedure
measure: Immersion during hypnosis
timeFrame: at the procedure
measure: Evaluation of the nociceptive response to painful stimuli
timeFrame: during the procedure
measure: Satisfaction with the procedure
timeFrame: after the procedure
measure: Duration of the procedure
timeFrame: after the procedure
measure: Length of stay in hospital / outpatient care
timeFrame: at 1 month
measure: Success of biopsies
timeFrame: at 1 month
measure: Need for general anesthesia
timeFrame: after the procedure
measure: Pain upon returning home the same evening and on D1
timeFrame: after procedure, at 1 day after procedure
measure: Adverse effects related to the procedure during one month
timeFrame: at 1 month
measure: Qualitative assessment of the patient's experience
timeFrame: after the procedure
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: university grenoble hospital
name: Gaelle GF FIARD, professor
role: PRINCIPAL_INVESTIGATOR
References: