An interventional study of Hypnosis 3D virtual reality headset in Renal Calculi and Pain, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.
The study is for patients undergoing shock wave lithotripsy in outpatient surgery unit.
It is proposed that using hypnosis with 3D virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients.
Remifentanil is an opioid commonly used for lithotripsy. Shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. Opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting
It is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.
The study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3D virtual reality headset (intervention) or no hypnosis and no 3D virtual reality headset (control group).
Patients will be followed up prior to hospital discharge to assess their remifentanil use and pain, anxiety, comfort and their satisfaction with 3D virtual reality headset.
This new device is a non-pharmacological adjunct and can reduce pain intensity during procedure, reduce opioid use and length of stay in hospital and improve the patient experience whilst potentially reducing complications of intravenous opioid.
This study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's planned enrollment of 106 is above the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Use of Hypnosis 3D virtual reality headset
Device: Hypnosis 3D virtual reality headset
Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone
3D experience to journey through a natural and therapeutic environment. Immersion is amplified by the realism of 3D environment, a soothing sound atmosphere and specific medical hypnosis.
Remifentanil use
Remifentanil consumption (microgram) during shock wave lithotripsy
Time frame: Hour 1
Maximal level of pain during shock wave lithotripsy
Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy
Time frame: Hour 1
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris