Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 4:45 AM
Study NCT ID:
NCT05092906
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2021-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Hypnosis During a Lumbar Puncture.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum pain felt during LP', 'timeFrame': 'Immediately at the end of LP procedure', 'description': 'The maximum pain experienced will be assessed in the immediate post procedure using a Numeric Pain Rating Scale (NPRS). The NPRS is a 10 points scale, ranging from 0 (no pain) to 10 (maximal pain).'}], 'secondaryOutcomes': [{'measure': 'Comfort felt during LP', 'timeFrame': 'Immediately at the end of LP procedure', 'description': 'The comfort level felt during the LP procedure will be assessed with a Numeric Rating Scale (NRS). The NRS is a 10 points scale, ranging from 0 (total uncomfort) to 10 (maximal comfort).'}, {'measure': 'Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.', 'timeFrame': 'Immediately at the end of LP procedure', 'description': 'Comparison between the two groups of the ratio of patient with a NPRS \\>= 4.'}, {'measure': 'Acceptation of hypnosis', 'timeFrame': 'Day1', 'description': 'Number and percentage of subjects randomized and analyzed in the hypnoanalgesia group and who have actually had hypnosis'}, {'measure': 'State and Trait anxiety before LP', 'timeFrame': 'Before randomization', 'description': 'The state and trait anxiety will be assess using the State and Trait anxiety inventory (STAI) questionnaire.'}, {'measure': 'Assess pain at Day 3 and Day 7', 'timeFrame': 'Three days and then seven days after the LP.', 'description': 'The pain level will be assess using the NPRS scale by telephonic interview.'}, {'measure': 'Timeframe for resumption of usual activities.', 'timeFrame': 'Seven days after the LP.', 'description': 'Number of days between LP and the resumption of usual activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar puncture', 'anxiety'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.', 'detailedDescription': "This study will follow the zelen's methodology randomization. It is an add-on study design.\n\n1. The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.\n2. Patients are asked to sign the consent of the standard of care group.\n3. Randomization into two equally sized groups:\n\n * Intervention arm : LP with complementary hypnoanalgesia\n * Control arm : LP without complementary hypnoanalgesia\n4. Patients who have been randomized into the control group, will have LP according to the standard of care.\n\nPatients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.\n\n* if the patient accepts, he will benefit from hypnosis during LP.\n* if the patient refuses, he will re-join the control group without hypnosis.\n\nThe physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Required a lumbar puncture for diagnosis\n* Affiliated with social security system\n* Patient's written consent\n\nExclusion Criteria:\n\n* LP contraindication\n* History of previous LP\n* Psychiatric disorder making the realization of a hypnosis irrelevant\n* Cognitive-behavioural abilities that do not allow the completion of the study\n* Persons who are protected under the act. Person deprived of liberty by judicial decision\n* Pregnant or Breastfeeding woman"}, 'identificationModule': {'nctId': 'NCT05092906', 'acronym': 'HYPNOPLUS', 'briefTitle': 'Contribution of Hypnosis During a Lumbar Puncture.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.', 'orgStudyIdInfo': {'id': '38RC20.357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar puncture with standard of care', 'interventionNames': ['Other: LP with standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'Lumbar puncture with hypnosis add-on therapy', 'interventionNames': ['Other: LP with complementary hypnoanalgesia']}], 'interventions': [{'name': 'LP with complementary hypnoanalgesia', 'type': 'OTHER', 'description': 'The lumbar puncture technique will be identical to that of the group standard of care. Hypnosis will be performed by a health professional trained in this practice, in addition to the standard analgesic management.', 'armGroupLabels': ['Lumbar puncture with hypnosis add-on therapy']}, {'name': 'LP with standard of care', 'type': 'OTHER', 'description': 'The LP will be carried out according to the usual techniques without hypnosis.\n\nStandard analgesic treatments will be used (except contraindications):\n\n* EMLA (Lidocain+Prilocain) Cream/Patch\n* Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable\n* Nitrous oxide', 'armGroupLabels': ['Lumbar puncture with standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Isere', 'country': 'France', 'facility': 'Neurology department of Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}