{
  "FullStudy":{
    "Rank":217876,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515683",
          "OrgStudyIdInfo":{
            "OrgStudyId":"AA"
          },
          "Organization":{
            "OrgFullName":"Odense University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Behavioral Support Before Anesthesia",
          "OfficialTitle":"Behavioral Support to Cancer Patients Before Anesthesia",
          "Acronym":"STØB"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 15, 2011",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 5, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 6, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Marianne K. Thygesen",
            "ResponsiblePartyInvestigatorTitle":"Development Nurse - Researcher",
            "ResponsiblePartyInvestigatorAffiliation":"Odense University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Odense University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Studies shows that reduced nervousness before anaesthesia may improve a course past anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly before anaesthesia. A RCT with three intervention arms (with different personal support) and a control arm (with usual personal support) is therefore performed.\n\nHypothesis: Nervousness is reduced by the new interventions compared to the usual help provided.",
          "DetailedDescription":"All patients receive behavioral support the last half hour before anaesthesia, but at different times and provided by persons with different connection to the patients.\n\nThe last two patients in all arms will be interviewed about their experiences with the help offered.\n\nStatistic will provide results in the quantitative part of the study and analysis and interpretation following ideas of the French philosopher Poul Ricoeur will provide results in the qualitative part of the study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Nervousness",
              "Life Experiences"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Nervousness before anesthesia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"350",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"An anaesthetic nurse",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Only support from an anaesthetic nurse on the surgery ward"
                  ]
                }
              },{
                "ArmGroupLabel":"Theatre nurse + An anaesthetic nurse",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Support from theatre nurse and an anaesthetic nurse",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Support: a theatre nurse + an anaesthetic nurse"
                  ]
                }
              },{
                "ArmGroupLabel":"A nurse from ward + an anaesthesic nurse",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Support from a nurse from the ward and an anaesthetic nurse",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Support: a nurse from the ward + an anaesthetic nurse"
                  ]
                }
              },{
                "ArmGroupLabel":"Optional relative + an anaesthetic nurse",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Support from an optional relative and an anaesthetic nurse",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Optional relative supports"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Only support from an anaesthetic nurse on the surgery ward",
                "InterventionDescription":"Additional staff are only present if required by law.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "An anaesthetic nurse"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Nursing care from an anaesthetic nurse"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Support: a theatre nurse + an anaesthetic nurse",
                "InterventionDescription":"Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Theatre nurse + An anaesthetic nurse"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Care from a theatre nurse"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Support: a nurse from the ward + an anaesthetic nurse",
                "InterventionDescription":"A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "A nurse from ward + an anaesthesic nurse"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Nursing care from a ward nurse"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Optional relative supports",
                "InterventionDescription":"Optional relative follows the patient to the operating table and stays with her until she is anaesthetized",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Optional relative + an anaesthetic nurse"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Care from an optional relative"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from baseline in nervousness at the operating table",
                "PrimaryOutcomeDescription":"VAS score shown by patients and written down by the anesthetic nurse correcte to one decimal place.",
                "PrimaryOutcomeTimeFrame":"Baseline and when the patient is on the operating table, on average 1½ days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Satisfaction with help from healthcare professionals",
                "SecondaryOutcomeDescription":"A validated questionnaire is filed out by patients. The questionnaire have six items measuring satisfaction with help from healthcare professionals provided at the hospital.",
                "SecondaryOutcomeTimeFrame":"A questionnaire at discharge, an expected average of three days"
              },{
                "SecondaryOutcomeMeasure":"Healthcare professional time spent",
                "SecondaryOutcomeDescription":"Healthcare professional time spent on interventions: Healthcare professional time used with patient and relative half an hour before anaesthesia byond what is required by law",
                "SecondaryOutcomeTimeFrame":"The last half an hour before anaesthesia"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll Danish-speaking expected gynaecological cancer patients, who are offered open surgery at Odense University Hospital, who can speak for themselves and have the opportunity to have close relative to follow before anaesthesia and who accept participation.\n\nExclusion Criteria:\n\nSenility",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ole Mogensen, Professor",
                "OverallOfficialAffiliation":"Southern University of Denmark",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Gynækologisk obstetrisk afdeling D, Odense Universitetshospital",
                "LocationCity":"Odense",
                "LocationState":"Fyn",
                "LocationZip":"5000",
                "LocationCountry":"Denmark"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000000777",
                "InterventionMeshTerm":"Anesthetics"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002492",
                "InterventionAncestorTerm":"Central Nervous System Depressants"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M2688",
                "InterventionBrowseLeafName":"Anesthetics",
                "InterventionBrowseLeafAsFound":"Anesthetic",
                "InterventionBrowseLeafRelevance":"high"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"CNSDep",
                "InterventionBrowseBranchName":"Central Nervous System Depressants"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}