Lithotripsy and Analgesia With 3D Hypnosis Mask (LAHMA)
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|ClinicalTrials.gov Identifier: NCT04869293|
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : April 19, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Renal Calculi Pain||Device: Hypnosis 3D virtual reality headset||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)|
|Actual Study Start Date :||April 15, 2021|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Experimental: 3D virtual reality
Use of Hypnosis 3D virtual reality headset
Device: Hypnosis 3D virtual reality headset
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.
No Intervention: Control
Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone
- Remifentanil use [ Time Frame: Hour 1 ]Remifentanil consumption (microgram) during shock wave lithotripsy
- Maximal level of pain during shock wave lithotripsy [ Time Frame: Hour 1 ]Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Shock wave lithotripsy and outpatient surgery
- Deafness, Blindness
- Schizophrenia, Hallucinations
- No french-speaking
- Motion sickness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04869293
|Contact: Darless Clausse, MD||331 56 09 54 firstname.lastname@example.org|
|Contact: Natacha Nohilé||331 56 09 59 email@example.com|
|Assistance Publique Hôpitaux de Paris, Necker||Not yet recruiting|
|Contact: Darless Clausse, MD|
|Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou||Recruiting|
|Paris, Île-de-France, France, 75015|
|Contact: Darless CLAUSSE, MD 331 56 09 54 11 firstname.lastname@example.org|
|Principal Investigator:||Darless Clausse, MD||Hôpital européen Geroges-Pompidou|
|Responsible Party:||Assistance Publique - Hôpitaux de Paris|
|Other Study ID Numbers:||
IDRCB 2020-A02052-37 ( Other Identifier: ANSM )
|First Posted:||May 3, 2021 Key Record Dates|
|Last Update Posted:||April 19, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared|
Informed Consent Form (ICF)
|Time Frame:||Two years after the last publication|
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Collaboration will be fostered.
Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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