Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT04869293
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lithotripsy and Analgesia With 3D Hypnosis Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remifentanil use', 'timeFrame': 'Hour 1', 'description': 'Remifentanil consumption (microgram) during shock wave lithotripsy'}], 'secondaryOutcomes': [{'measure': 'Maximal level of pain during shock wave lithotripsy', 'timeFrame': 'Hour 1', 'description': 'Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['therapeutic virtual reality', 'hypnosis'], 'conditions': ['Renal Calculi', 'Pain']}, 'referencesModule': {'references': [{'pmid': '31136330', 'type': 'BACKGROUND', 'citation': 'Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.'}, {'pmid': '29395400', 'type': 'BACKGROUND', 'citation': 'Scapin S, Echevarria-Guanilo ME, Boeira Fuculo Junior PR, Goncalves N, Rocha PK, Coimbra R. Virtual Reality in the treatment of burn patients: A systematic review. Burns. 2018 Sep;44(6):1403-1416. doi: 10.1016/j.burns.2017.11.002. Epub 2018 Feb 1.'}, {'pmid': '30052655', 'type': 'BACKGROUND', 'citation': 'Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study is for patients undergoing shock wave lithotripsy in outpatient surgery unit.\n\nIt 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.\n\nRemifentanil 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\n\nIt is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.\n\nThe 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).\n\nPatients 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.\n\nThis 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.\n\nThis study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Shock wave lithotripsy and outpatient surgery\n\nExclusion Criteria:\n\n* Epilepsy\n* Deafness, Blindness\n* Schizophrenia, Hallucinations\n* No french-speaking\n* Autistic\n* Motion sickness'}, 'identificationModule': {'nctId': 'NCT04869293', 'acronym': 'LAHMA', 'briefTitle': 'Lithotripsy and Analgesia With 3D Hypnosis Mask', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)', 'orgStudyIdInfo': {'id': 'APHP200879'}, 'secondaryIdInfos': [{'id': 'IDRCB 2020-A02052-37', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D virtual reality', 'description': 'Use of Hypnosis 3D virtual reality headset', 'interventionNames': ['Device: Hypnosis 3D virtual reality headset']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone'}], 'interventions': [{'name': 'Hypnosis 3D virtual reality headset', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['3D virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Darless Clausse, MD', 'role': 'CONTACT'}], 'facility': 'Assistance Publique Hôpitaux de Paris, Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Darless CLAUSSE, MD', 'role': 'CONTACT', 'email': 'darless.clausse@aphp.fr', 'phone': '331 56 09 54 11'}], 'facility': 'Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Darless Clausse, MD', 'role': 'CONTACT', 'email': 'darless.clausse@aphp.fr', 'phone': '331 56 09 54 11'}, {'name': 'Natacha Nohilé', 'role': 'CONTACT', 'email': 'natacha.nohile@aphp.fr', 'phone': '331 56 09 59 82'}], 'overallOfficials': [{'name': 'Darless Clausse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital européen Geroges-Pompidou'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', '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', 'accessCriteria': '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.\n\nData 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.\n\nProcessing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'GAMIDA', 'class': 'UNKNOWN'}, {'name': 'Healthy Mind', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}