Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-30 @ 7:57 AM
Study NCT ID:
NCT00913861
Status:
TERMINATED
Last Update Posted:
2014-06-03
First Post:
2009-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-pharmacological Intervention for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D015742', 'term': 'Propofol'}], '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'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': "affiliation's change of the principal investigator need a new review bord", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2009-05-22', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total dose of propofol', 'timeFrame': 'the day of the colonoscopy, at the end'}], 'secondaryOutcomes': [{'measure': "gastroenterologist's satisfaction and quality of the colonoscopy", 'timeFrame': 'the day of the procedure, at the end of the procedure'}, {'measure': 'vital parameters', 'timeFrame': 'during all the procedure, every 5 minutes'}, {'measure': "patient's comfort", 'timeFrame': 'during the procedure every 10 minutes and 1 and 14 days after the colonoscopy'}, {'measure': 'anxiety state', 'timeFrame': 'between 30 minutes to one hour before coloscopy and between 5 minutes and 1 hour after the end of the procedure'}, {'measure': "patient's satisfaction", 'timeFrame': 'between 5 minutes to 1 hour after the end of the procedure and 1 and 14 days after the colonoscopy'}, {'measure': 'duration of the procedure', 'timeFrame': 'the day of the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endoscopy', 'comfort', 'non-pharmacological'], 'conditions': ['Colonoscopy', 'Sedation', 'Hypnosis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.", 'detailedDescription': "Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients classified as ASA 1 to 3\n* colonoscopy with anesthesiological support\n* capacity of consenting\n\nExclusion Criteria:\n\n* pregnancy\n* colonoscopy with gastroscopy\n* emergency\n* psychotic diseases\n* deafness\n* incapacity to understand french\n* addiction of drugs and alcohol\n* psychoactive drugs'}, 'identificationModule': {'nctId': 'NCT00913861', 'briefTitle': 'Non-pharmacological Intervention for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Does Non-pharmacological Intervention Reduce Consumption of Propofol During Colonoscopy?', 'orgStudyIdInfo': {'id': '08-238'}, 'secondaryIdInfos': [{'id': 'NAC 08-072'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard sedation', 'description': 'propofol and fentanyl', 'interventionNames': ['Drug: standard sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'structured attention-standard sedation', 'description': 'structured attention', 'interventionNames': ['Behavioral: Structured attention']}, {'type': 'EXPERIMENTAL', 'label': 'hypnosis-standard sedation', 'description': 'hypnosis', 'interventionNames': ['Behavioral: hypnosis']}], 'interventions': [{'name': 'hypnosis', 'type': 'BEHAVIORAL', 'otherNames': ['hypnotic state'], 'description': 'Hypnosis: induction of hypnosis by visual fixation and recollection of a pleasant memory, suggestion of relaxation, of self-control and post-hypnotic suggestion for bowel relaxation.', 'armGroupLabels': ['hypnosis-standard sedation']}, {'name': 'standard sedation', 'type': 'DRUG', 'otherNames': ['Disoprivan (propofol)and fentanyl'], 'description': 'Standard sedation: fentanyl 2x0,5 microg/kg at beginning of procedure and propofol PCS: 20mg bolus than 10mg/bolus, lock-out = 0.', 'armGroupLabels': ['standard sedation']}, {'name': 'Structured attention', 'type': 'BEHAVIORAL', 'otherNames': ['psychological support'], 'description': 'Structured attention: verbal and nonverbal communication; attentive listening; provision of the perception of control; encouragement; use of emotionally neutral descriptors, focus on a sensations.', 'armGroupLabels': ['structured attention-standard sedation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Division of Anesthesiology, University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Nicole Cheseaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Anesthesiology, University Hospitals, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cheseaux Nicole', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}