Prostate BiopsyHYPNOSURG-VRNCT06691438
Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia:
A study testing prostate biopsy in people with Prostate Biopsy, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
- Patient having signed informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Biopsy
- Being tested
- prostate biopsy
- Keywords
- Sedation, Pain, Hypnosis, Virtual Reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate biopsyDevice
Also called experimental
prostate biopsies with virtual reality hypnosis headset
| Study group | Role | What they receive |
|---|---|---|
| prostate biopsies without virtual reality hypnosis headset | Active comparator | Biopsies are performed according to current recommendations Receives: Device: prostate biopsy |
| prostate biopsies with virtual reality hypnosis headset | Experimental | Patient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure. Receives: Device: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after the procedure
Secondary outcomes (12)
Pain after the procedure
Numerical scale 0-10 of pain upon discharge from the hospital
Measured: 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
Measured: after the procedure
Immersion during hypnosis
Immersion scale from 0 to 10 during hypnosis
Measured: at the procedure
Evaluation of the nociceptive response to painful stimuli
Heart rate variability (= HRV) on the ECG trace (in milliseconds)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 1 month
Success of biopsies
Number of biopsies performed/planned (ratio), achievement of the MRI target (Yes/no)
Measured: at 1 month
Need for general anesthesia
Rate of need for general anesthesia (in %)
Measured: 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
Measured: 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
Measured: at 1 month
Qualitative assessment of the patient's experience
Semi-directed interview directly after the procedure
Measured: after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EssaiClinique_HYPNOSURG-VR, University Hospital, Grenoble
- Investigators
- Gaelle GF FIARD, professor, Principal investigator, university grenoble hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691438
- Sponsor's protocol ID
- EssaiClinique_HYPNOSURG-VR
- Acronym
- HYPNOSURG-VR
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06691438
- Acronym / sponsor ID
- HYPNOSURG-VR / EssaiClinique_HYPNOSURG-VR
- Conditions
- Prostate Biopsy
- Keywords
- Sedation, Pain, Hypnosis, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostate biopsies without virtual reality hypnosis headset | Active comparator | Device: prostate biopsyBiopsies are performed according to current recommendations |
| prostate biopsies with virtual reality hypnosis headset | Experimental | Device: prostate biopsyPatient wearing a virtual reality headset put in place in the transfer room 15 minutes before the procedure and maintained throughout the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
- Patient having signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prostate biopsyAlso: experimentalprostate biopsies with virtual reality hypnosis headset | Device | prostate biopsies with virtual reality hypnosis headset, prostate biopsies without virtual reality hypnosis headset |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaelle GF FIARD, professor principal investigator
university grenoble hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostate biopsy in people with Prostate Biopsy, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaelle GF FIARD, Professor (0476767642 ext. +33, gfiard@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.