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Lithotripsy and Analgesia With 3D Hypnosis Mask (LAHMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869293
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : April 19, 2023
Sponsor:
Collaborators:
GAMIDA
Healthy Mind
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Calculi Pain Device: Hypnosis 3D virtual reality headset Not Applicable

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).

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Remifentanil use [ Time Frame: Hour 1 ]
    Remifentanil consumption (microgram) during shock wave lithotripsy


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Shock wave lithotripsy and outpatient surgery

Exclusion Criteria:

  • Epilepsy
  • Deafness, Blindness
  • Schizophrenia, Hallucinations
  • No french-speaking
  • Autistic
  • Motion sickness
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Darless Clausse, MD 331 56 09 54 11 darless.clausse@aphp.fr
Contact: Natacha Nohilé 331 56 09 59 82 natacha.nohile@aphp.fr

Locations
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France
Assistance Publique Hôpitaux de Paris, Necker Not yet recruiting
Paris, France
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    darless.clausse@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
GAMIDA
Healthy Mind
Investigators
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Principal Investigator: Darless Clausse, MD Hôpital européen Geroges-Pompidou
More Information
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Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04869293    
Other Study ID Numbers: APHP200879
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
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Two years after the last publication
Access Criteria:

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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
therapeutic virtual reality
hypnosis
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urolithiasis
Urinary Calculi
Male Urogenital Diseases