Lithotripsy and Analgesia With 3D Hypnosis Mask

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)

Conditions
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Renal Calculi, Pain

Intervention / Treatment
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* Device: Hypnosis 3D virtual reality headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Shock wave lithotripsy and outpatient surgery Exclusion Criteria: Epilepsy Deafness, Blindness Schizophrenia, Hallucinations No french-speaking Autistic Motion sickness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D virtual reality<br>Use of Hypnosis 3D virtual reality headset | Device: Hypnosis 3D virtual reality headset<br>* 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.<br>|
| No Intervention: Control<br>Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil use | Remifentanil consumption (microgram) during shock wave lithotripsy | Hour 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal level of pain during shock wave lithotripsy | Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy | Hour 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic virtual reality, hypnosis