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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
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.
Assistance Publique Hôpitaux de Paris, Necker
Paris, France
NOT_YET_RECRUITINGAssistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France
RECRUITINGRemifentanil 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
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