Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 5:43 AM
Study NCT ID:
NCT04399850
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Hypnosis During Invasive Procedure in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain distress', 'timeFrame': 'within the before and the first hour after the procedure', 'description': 'Pain distress change in the hypnosis group measured before and within the first hour after the procedure.\n\nPain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress).'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'within first hour and first 24 hours after procedure', 'description': 'Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).'}, {'measure': 'Number of adverse events', 'timeFrame': 'during procedure'}, {'measure': 'Length of each painful procedure', 'timeFrame': 'up to 3 months'}, {'measure': 'Analgesia dose', 'timeFrame': 'within first and 24 hours after procedure', 'description': 'The dose of each analgesia treatment received by the patient will be collected.'}, {'measure': 'Type of analgesia', 'timeFrame': 'within first and 24 hours after procedure', 'description': 'The type of each analgesia treatment received by the patient will be collected.'}, {'measure': 'Anxiety', 'timeFrame': 'within first and 24 hours after procedure', 'description': 'Anxiety within first and 24 hours after procedure will be assessed using Numeric rating scale, which goes from 0 (no anxiety) to 10 (maximum anxiety imaginable).'}, {'measure': 'Hospital Anxiety and Depression (HAD) scale', 'timeFrame': 'at 3 months', 'description': 'The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.\n\nHAD scale is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.'}, {'measure': 'Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)', 'timeFrame': 'at 3 months', 'description': 'The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 to 4 . The IES-R yields a total score (ranging from 0 to 88)'}, {'measure': 'Proportion of patients who had hypnosis transe', 'timeFrame': 'during procedure'}, {'measure': 'Description of the experience of hypnosis', 'timeFrame': 'at 3 months', 'description': 'Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive procedure', 'pain distress', 'hypnosis'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': "Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years and older\n* ICU hospitalisation\n* Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)\n* Physician experienced in hypnosis available\n* written informed consent\n* health insurance\n\nExclusion Criteria:\n\n* sedation and intubation, delirium, end-of-life decision,\n* deaf patient,\n* patient who does not understand French language,\n* pregnancy\n* patient under guardianship or curatorship\n* lack of health insurance'}, 'identificationModule': {'nctId': 'NCT04399850', 'acronym': 'HYPNOICU', 'briefTitle': 'Impact of Hypnosis During Invasive Procedure in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Hypnosis During Invasive Procedure in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'APHP191042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients who receive hypnosis', 'description': 'Patients who receive hypnosis during procedure by experiment physician', 'interventionNames': ['Other: Hypnosis group']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patient with conventional pain management'}], 'interventions': [{'name': 'Hypnosis group', 'type': 'OTHER', 'description': 'Patients who receive hypnosis', 'armGroupLabels': ['Patients who receive hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}