Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 2:57 PM
Study NCT ID:
NCT04129333
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2019-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-15', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0)', 'description': 'Oral assessment scale (0 : no pain - 10 : maximal pain)'}], 'secondaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'The first hour after the end of the procedure (Hour 1)', 'description': 'Oral assessment scale (0 : no pain - 10 : maximal pain)'}, {'measure': 'Morphine equivalent dose', 'timeFrame': 'Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)', 'description': 'Cumulative use of morphine-morphine analgesics in morphine equivalent during the procedure and the first hour after the end of the procedure (H1)'}, {'measure': 'Sedatives dose', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)', 'description': 'Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1)'}, {'measure': 'Local Anesthesia dose', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0)', 'description': 'Consumption of local anesthesia during the invasive procedure'}, {'measure': 'Comfort scale', 'timeFrame': 'Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)', 'description': 'Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable)'}, {'measure': 'Anxiety', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)', 'description': 'Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) .'}, {'measure': 'Duration', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0)', 'description': 'Duration of the invasive procedure including the period of hypnosis'}, {'measure': 'Number of attempts and failures of the procedure', 'timeFrame': 'The first hour after the end of the procedure (Hour 1)', 'description': 'Number of attempts and failures of the procedure'}, {'measure': 'Adverse events', 'timeFrame': 'The first hour after the end of the procedure (Hour 1)', 'description': 'Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)'}, {'measure': 'Nurse stress', 'timeFrame': 'Immediately after the end of the invasive procedure (Hour 0)', 'description': 'Stress of the nurse in charge of the patient quantified by a numerical scale of evaluation (0 no stress - 10 greatest stress imaginable)'}, {'measure': 'Length of stay in intensive care unit', 'timeFrame': 'Day 28', 'description': 'Length of stay in intensive care unit, measured until D28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Procedure']}, 'referencesModule': {'references': [{'pmid': '40682163', 'type': 'DERIVED', 'citation': 'Maamar A, Faleur C, Pedrono K, Adeux MP, Anne M, Verdes A, Fillatre P, Debarre M, Mercier N, Revest M, Massart N, Poilvet N, Terzi N, Tadie JM, Gacouin A, Laviolle B. Hypnosis for unplanned procedural pain in the intensive care unit: the HYPIC randomized clinical trial. Crit Care. 2025 Jul 18;29(1):312. doi: 10.1186/s13054-025-05563-9.'}]}, 'descriptionModule': {'briefSummary': 'Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient admitted to intensive care\n* Glasgow score = 15\n* Necessity during the stay of making an invasive gesture among:\n* Thoracic drainage\n* Placement of a central venous catheter or a Swan-Ganz catheter\n* Establishment of a dialysis catheter\n* Introduction of an invasive arterial catheter\n* Patient giving free, informed and written consent\n* Patient affiliated to a social security scheme\n\nNon inclusion Criteria:\n\n* Procedure to be carried out in extreme urgency\n* Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)\n* Decompensated psychiatric illness\n* Patient sedated or intravenous analgesia continued at the time of the procedure\n* Patient intubated\n* Patient with a contraindication to sedation or analgesia at the time of the procedure\n* Patient receiving topical anesthesia before the start of the procedure\n* Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty\n* Patient already included in the study during the completion of a previous invasive procedure\n* Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug'}, 'identificationModule': {'nctId': 'NCT04129333', 'acronym': 'HYPIC', 'briefTitle': 'HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '35RC18_8853_HYPIC'}, 'secondaryIdInfos': [{'id': '2019-A01775-52', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypnosis group', 'description': 'A hypnosis group with standard care during the invasive procedure according to the usual practice of the care team and setting up a hypnotic accompaniment by an nurse trained beforehand and dedicated throughout the gesture. The hypnosis session will end at the same time as the invasive procedure.', 'interventionNames': ['Other: Hypnosis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'A control group with standard care during the invasive procedure according to the usual practice of the care team.', 'interventionNames': ['Other: No hypnosis']}], 'interventions': [{'name': 'Hypnosis', 'type': 'OTHER', 'description': 'The hypnosis session :\n\n* Creation of the therapist-patient link\n* Choice of a theme and the preferred sensory channel by the patient\n* Collection of the theme chosen by the patient\n* Orientation in the here and now.\n* Induction\n* Realization of the gesture and hypnosis\n* At the end of the procedure, reassociation of the patient in the here and now', 'armGroupLabels': ['Hypnosis group']}, {'name': 'No hypnosis', 'type': 'OTHER', 'description': 'No hypnosis', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Saint-Brieuc', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Saint-Brieuc Hospital', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}