Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prostate biopsy.
- Who it may be relevant to
- Registry conditions: Prostate Biopsy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device prostate biopsy
prostate biopsies with virtual reality hypnosis headset
Primary outcome measures
- 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. [Time frame: after the procedure]
Secondary outcome measures (12)
- Pain after the procedure [Time frame: when leaving the hospital]
- Stress during the procedure [Time frame: after the procedure]
- Immersion during hypnosis [Time frame: at the procedure]
- Evaluation of the nociceptive response to painful stimuli [Time frame: during the procedure]
- Satisfaction with the procedure [Time frame: after the procedure]
- Duration of the procedure [Time frame: after the procedure]
- Length of stay in hospital / outpatient care [Time frame: at 1 month]
- Success of biopsies [Time frame: at 1 month]
- Need for general anesthesia [Time frame: after the procedure]
- Pain upon returning home the same evening and on D1 [Time frame: after procedure, at 1 day after procedure]
- Adverse effects related to the procedure during one month [Time frame: at 1 month]
- Qualitative assessment of the patient's experience [Time frame: after the procedure]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- University Hospital Grenoble — Grenoble
Identifiers
NCT: NCT06691438 · EssaiClinique_HYPNOSURG-VR