Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-02-25 @ 9:23 PM
Study NCT ID:
NCT04185233
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2019-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distraction and Nitrous Oxide for Venous Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction score', 'timeFrame': 'From time of venous puncture until 1 hour afterwards', 'description': 'Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).'}], 'primaryOutcomes': [{'measure': 'Anxiety score', 'timeFrame': 'From one hour prior to venous puncture until 1 hour afterwards', 'description': 'Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards. The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'From one hour prior to venous puncture until 1 hour afterwards', 'description': 'Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nitrous oxide', 'distraction'], 'conditions': ['Anxiety', 'Pain', 'Venous Puncture']}, 'descriptionModule': {'briefSummary': 'This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.', 'detailedDescription': 'The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.\n\nThe primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.\n\nAll children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Venous track needed\n* French mother tongue\n* Age between 3 and 9 years old\n\nExclusion Criteria:\n\n* Children with cognitive disorder (autism, metabolic disorders,\n* Children with cerebral-motor disability\n* Children who don't speak french\n* Children with ADHD treatment\n* Children with epilepsy\n* Children who present contraindication to the use of Nitrous oxide"}, 'identificationModule': {'nctId': 'NCT04185233', 'acronym': 'DISPO', 'briefTitle': 'Distraction and Nitrous Oxide for Venous Puncture', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'in progress'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iPad distraction', 'description': 'Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time.\n\nIntervention : game on iPad', 'interventionNames': ['Other: Games on an iPad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nitrous Oxide', 'description': 'Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time.\n\nIntervention : Nitrous Oxide', 'interventionNames': ['Drug: Nitrous Oxide']}], 'interventions': [{'name': 'Games on an iPad', 'type': 'OTHER', 'description': 'Many games will be programmed on the iPad and organized by age. The child will choose one game and play it during all the procedure time.', 'armGroupLabels': ['iPad distraction']}, {'name': 'Nitrous Oxide', 'type': 'DRUG', 'description': 'Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.', 'armGroupLabels': ['Nitrous Oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1206', 'city': 'Geneva', 'country': 'Switzerland', 'facility': "Geneva Children's Hospital", 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Manon Cadoux, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}, {'name': 'Virginie Luscher, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Walid HABRE', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}