Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Remifentanil use
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Shock wave lithotripsy and outpatient surgery
Exclusion Criteria
- •Deafness, Blindness
- •Schizophrenia, Hallucinations
- •No french-speaking
- •Motion sickness
Outcomes
Primary Outcomes
Remifentanil use
Time Frame: Hour 1
Remifentanil consumption (microgram) during shock wave lithotripsy
Secondary Outcomes
- Maximal level of pain during shock wave lithotripsy(Hour 1)