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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Grenoble

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route

Patient having signed informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • prostate biopsy

    Device

    prostate biopsies with virtual reality hypnosis headset

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: prostate biopsies without virtual reality hypnosis headsetActive comparator 1 intervention
Group B: prostate biopsies with virtual reality hypnosis headsetExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
after the procedure

Secondary outcomes

1

Pain after the procedure

Numerical scale 0-10 of pain upon discharge from the hospital

Time frame
when leaving the hospital
2

Stress during the procedure

Numerical stress scale from 0 to 10 upon arrival of the patient, and 15 minutes after the procedure

Time frame
after the procedure
3

Immersion during hypnosis

Immersion scale from 0 to 10 during hypnosis

Time frame
at the procedure
4

Evaluation of the nociceptive response to painful stimuli

Heart rate variability (= HRV) on the ECG trace (in milliseconds)

Time frame
during the procedure

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: