Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01084018
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
2010-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'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': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-14', 'studyFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-03-09', 'lastUpdatePostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': '24, 48, 72 hrs, 7 days, 6 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute postoperative pain', 'nursing intervention'], 'conditions': ['Cardiac Surgery', 'Pain', 'Adult', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '23241361', 'type': 'DERIVED', 'citation': 'Martorella G, Cote J, Racine M, Choiniere M. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial. J Med Internet Res. 2012 Dec 14;14(6):e177. doi: 10.2196/jmir.2070.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery.\n\nThe hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing.\n\nA pilot-RCT is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first intention cardiac surgery\n* 18 years old or more\n* able to fill up questionnaires in french\n\nExclusion Criteria:\n\n* participation to another psychosocial intervention\n* cognitive or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT01084018', 'acronym': 'SOULAGETAVIE', 'briefTitle': 'Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Development and Evaluation of a Nursing Virtual Intervention Tailored for Pain After Cardiac Surgery-SOULAGETAVIE', 'orgStudyIdInfo': {'id': 'CE 09.214'}}, 'armsInterventionsModule': {'interventions': [{'name': 'soulageTAVIE', 'type': 'BEHAVIORAL', 'description': "VITaPaCS consists in a 30 minute-computer-tailored preoperative session, which is animated by a virtual nurse who guides the participant through a learning process about analgesic medication intake, pain communication, and cognitive restructuring. The information and the strategies provided are specifically tailored to the participants' profile, determined by a screening questionnaire, but also by their responses in real-time during the computer session. Two postoperative clinical reinforcements of ten minutes are also provided by the treating nurse based on the flags identified through the preoperative session."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hotel-Dieu (CHUM)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'José Côté, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal"}, {'name': 'Manon Choinière, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal"}, {'name': 'Géraldine Martorella, PhD (c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'GRISIIQ', 'class': 'UNKNOWN'}, {'name': 'FIIC', 'class': 'UNKNOWN'}, {'name': 'Chaire de recherche sur les nouvelles pratiques de soins infirmiers', 'class': 'UNKNOWN'}, {'name': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'José Côté', 'oldOrganization': 'CRCHUM'}}}}