Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 8:44 AM
Study NCT ID:
NCT01595035
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2012-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average pain intensity', 'timeFrame': '1 week', 'description': 'Brief Pain Inventory'}], 'secondaryOutcomes': [{'measure': 'The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.', 'timeFrame': '1,2,3,7 day after surgery'}, {'measure': 'Pain occurence', 'timeFrame': '3 and 6 month after surgery', 'description': 'Brief Pain Inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Day surgery', 'Orthopedic surgery', 'Breast reconstruction surgery'], 'conditions': ['Postoperative Pain', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33432643', 'type': 'DERIVED', 'citation': 'Valeberg BT, Dihle A, Smastuen MC, Endresen AO, Rustoen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Apr;30(7-8):1132-1143. doi: 10.1111/jocn.15659. Epub 2021 Jan 25.'}]}, 'descriptionModule': {'briefSummary': "Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. The aim of this study is to enhance pain management by academic detailing (patients' current knowledge and motivations are the basis for information) and nurse coaching (frequent and individualized support). The study consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by a structured telephone interview; (2) development of an intervention to improve pain management; (3) implement and evaluate the intervention; (4) evaluate the incidence of chronic pain after day surgery. Even if patients are prescribed sufficient doses of analgesics, pain relief is dependent on patients' adherence with the analgesic regimen. Psychological factors, such as catastrophizing may also contribute to patients' experience of postoperative pain. Strategies that may be more effective than general information concerning surgery and pain management is academic detailing and nurse coaching, and will be used as frame for the intervention.\n\nHypothesis:\n\nOver the seven days after surgery patients in the intervention group report;\n\n* higher adherence with the analgesic regimen,\n* have less pain intensity and pain interference with function and\n* lower severity of side effects compared to the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age;\n* able, to read, write, and understand Norwegian;\n* are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and\n* have a telephone line.\n\nExclusion Criteria:\n\n* Staying overnight in hospital'}, 'identificationModule': {'nctId': 'NCT01595035', 'briefTitle': 'A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery', 'orgStudyIdInfo': {'id': '2011/1984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'counselling', 'description': 'Patients who receive the Pain booklet and support by telephone', 'interventionNames': ['Behavioral: psychoeducational']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'psychoeducational', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management', 'armGroupLabels': ['counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0130', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo and Akershus University College of Apllied Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Berit Valeberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo Metropolitan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}