Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 7:17 PM
Study NCT ID:
NCT02834156
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Child Positioning on Pain During a Lumbar Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensitivity during the lumbar puncture procedure.', 'timeFrame': 'duration of the procedure', 'description': 'It will be evaluated throw specific pain assessment scales according to patient age'}], 'secondaryOutcomes': [{'measure': 'Anxiety during the lumbar puncture procedure on a scale of one to ten', 'timeFrame': 'duration of the procedure'}, {'measure': 'Time of the lumbar puncture procedure', 'timeFrame': 'duration of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hematological Malignancies']}, 'descriptionModule': {'briefSummary': "This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.\n\nIt's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.", 'detailedDescription': 'In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.\n\nIn hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.\n\nTwo positions are possible to carry out lumbar puncture: seated or lying position.\n\nThe main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.\n\nThis study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.\n\nEach patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.\n\nAll data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 2 and 18 years old\n* Patients requiring at least 2 therapeutic lumbar punctures\n* Patients able to receive analgesic procedure according to 20005 good practices recommendation\n* Presence of one parent during LP procedure\n* Child able to use assessment scales\n* LP realized with a 20 G needle\n* Platelets \\> 50000\n* Child with prior clinical examination\n* Affiliated to a health care insurance regimen\n\nExclusion Criteria:\n\n* Seated or lying position impossible\n* Lumbar puncture contraindication\n* Patient or parent opposition to second LP realization in the required position\n* Clotting trouble on LP day not allowing the LP procedure'}, 'identificationModule': {'nctId': 'NCT02834156', 'acronym': 'PHIPA-PEPL', 'briefTitle': 'Impact of Child Positioning on Pain During a Lumbar Puncture', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children', 'orgStudyIdInfo': {'id': '15-PP-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LP in a seated position then LP in a lying position', 'description': 'Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position', 'interventionNames': ['Other: LP in a seated position then LP in a lying position']}, {'type': 'OTHER', 'label': 'LP in a lying position then LP in a seated position', 'description': 'Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position', 'interventionNames': ['Other: LP in a lying position then LP in a seated position']}], 'interventions': [{'name': 'LP in a seated position then LP in a lying position', 'type': 'OTHER', 'armGroupLabels': ['LP in a seated position then LP in a lying position']}, {'name': 'LP in a lying position then LP in a seated position', 'type': 'OTHER', 'armGroupLabels': ['LP in a lying position then LP in a seated position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}