Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-01 @ 2:25 PM
Study NCT ID:
NCT01976403
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2011-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Barriers to pain management', 'timeFrame': 'baseline'}, {'measure': 'pain sensitivity', 'timeFrame': 'baseline'}, {'measure': 'Hope', 'timeFrame': 'day 90, day 180, day 360'}, {'measure': 'Social support', 'timeFrame': 'day 90, day 180, day 360'}], 'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360', 'description': 'Change from Baseline in pain intensity at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360'}, {'measure': 'pain-related interference', 'timeFrame': 'Baseline, day 7, day 30, day 90, day 180, day 360', 'description': 'Change from Baseline in pain-related interference at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360'}], 'secondaryOutcomes': [{'measure': 'analgesic intake', 'timeFrame': 'baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360'}, {'measure': 'Quality of life', 'timeFrame': 'baseline, day 7, day 90, day 180, day 360'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Pain, Postoperative', 'Other Functional Disturbances Following Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '29291728', 'type': 'DERIVED', 'citation': 'Bjornnes AK, Parry M, Lie I, Falk R, Leegaard M, Rustoen T. The association between hope, marital status, depression and persistent pain in men and women following cardiac surgery. BMC Womens Health. 2018 Jan 2;18(1):2. doi: 10.1186/s12905-017-0501-0.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery.\n\nThe primary objectives are to:\n\n1. Develop and implement a pain booklet to improve pain management after cardiac surgery\n2. Evaluate the effect of the pain booklet compared to a group of patients given usual care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing their first elective CABG, valve surgery or a combination\n* receiving the standard preadmission information\n* able to take care of themselves after discharge\n* able to read and write Norwegian and fill in the questionnaires\n* able to be contacted by telephone\n\nExclusion Criteria:\n\n* more than 12 hours at the intensive care unit after surgery'}, 'identificationModule': {'nctId': 'NCT01976403', 'briefTitle': "Intervention Study to Enhance Patients' Pain Management After Cardiac Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': "AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery", 'orgStudyIdInfo': {'id': '2011/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain booklet', 'interventionNames': ['Behavioral: Pain Booklet']}, {'type': 'NO_INTERVENTION', 'label': 'standard care'}], 'interventions': [{'name': 'Pain Booklet', 'type': 'BEHAVIORAL', 'description': 'The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients', 'armGroupLabels': ['Pain booklet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Marit Leegaard, PhD RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo Metropolitan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marit Leegaard', 'investigatorAffiliation': 'Oslo Metropolitan University'}}}}