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NCT Number: 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:

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.

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Key information

Conditions

Prostate Biopsy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

prostate biopsy

Device

prostate biopsies with virtual reality hypnosis headset

Other names: experimental

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.

    Time frame: after the procedure

    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.

Secondary outcomes

  1. Pain after the procedure

    Time frame: when leaving the hospital

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

  2. Stress during the procedure

    Time frame: after the procedure

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

  3. Immersion during hypnosis

    Time frame: at the procedure

    Immersion scale from 0 to 10 during hypnosis

  4. Evaluation of the nociceptive response to painful stimuli

    Time frame: during the procedure

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

  5. Satisfaction with the procedure

    Time frame: after the procedure

    Desire to repeat this method of anesthesia in the event of an iterative procedure versus general anesthesia (yes/no)

  6. Duration of the procedure

    Time frame: after the procedure

    Duration of the procedure in minutes (time between the start of the procedure and the end of the procedure by the surgeon)

  7. Length of stay in hospital / outpatient care

    Time frame: at 1 month

    Length of stay in day hospital or outpatient care, in minutes (Time leaving the room - Time entering the room)

  8. Success of biopsies

    Time frame: at 1 month

    Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no)

  9. Need for general anesthesia

    Time frame: after the procedure

    Rate of need for general anesthesia (in %)

  10. Pain upon returning home the same evening and on D1

    Time frame: after procedure, at 1 day after procedure

    Numerical pain scale 0-10 on returning home the same evening and on D1 collected in the patient notebook

  11. Adverse effects related to the procedure during one month

    Time frame: at 1 month

    Patient notebook for collecting adverse effects for 1 month

  12. Qualitative assessment of the patient's experience

    Time frame: after the procedure

    Semi-directed interview directly after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Assilah AB BOUZIT, study co

CONTACT

[email protected]

0476767971 ext. +33

Gaelle GF FIARD, Professor

CONTACT

[email protected]

0476767642 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: HYPNOSURG-VR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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