Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT03428035
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-04-05', 'releaseDate': '2022-06-22'}], 'estimatedResultsFirstSubmitDate': '2022-06-22'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D011356', 'term': 'Product Labeling'}, {'id': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D019064', 'term': 'Product Packaging'}, {'id': 'D007221', 'term': 'Industry'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-05', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient reported adverse events', 'timeFrame': '6-9 days after surgery', 'description': 'Any reported adverse events'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '6-9 days after surgery', 'description': 'Correct initiation of therapy, correct intake amount, premature discontinuation of therapy'}, {'measure': 'Resource use', 'timeFrame': '6-9 days after surgery', 'description': 'e.g. provider contacts'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'package insert', 'nocebo'], 'conditions': ['Orthopedic Surgery']}, 'referencesModule': {'references': [{'pmid': '31349865', 'type': 'DERIVED', 'citation': 'Prediger B, Meyer E, Buchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials. 2019 Jul 26;20(1):458. doi: 10.1186/s13063-019-3565-3.'}]}, 'descriptionModule': {'briefSummary': 'Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.\n\nAim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.\n\nMethods Patients It is planned to include 60 patients in the study.\n\nIntervention\n\n* Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.\n* Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.\n\nControl Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).\n\nOutcomes\n\n* Number of patient reported adverse events (primary outcome).\n* Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).\n* Resource use (e.g. provider contacts).\n\nType of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective orthopaedic surgery\n* planned intake of ibuprofen 600 mg to treat postoperative pain\n* postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)\n* at least 18 years\n* able to speak German\n* no cognitive deficits\n* written informed consent\n\nExclusion Criteria:\n\n* serious comorbidity\n* pain medication prior to surgery\n* other medication with similar side effects\n* polytrauma\n* planned inpatient rehabilitation \\> one week after hospital discharge'}, 'identificationModule': {'nctId': 'NCT03428035', 'acronym': 'NEUPANO', 'briefTitle': 'The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.', 'organization': {'class': 'OTHER', 'fullName': 'University of Witten/Herdecke'}, 'officialTitle': 'Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence', 'orgStudyIdInfo': {'id': 'V01-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Package Insert', 'description': 'Simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.', 'interventionNames': ['Other: Package Insert']}, {'type': 'NO_INTERVENTION', 'label': 'Verbal Information', 'description': 'The patient is informed verbally about side effects and does not receive any package insert.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Package insert according to EU Directive 2001/83 / EC (usual package insert)', 'interventionNames': ['Other: Package Insert']}], 'interventions': [{'name': 'Package Insert', 'type': 'OTHER', 'otherNames': ['Patient Education'], 'description': 'Modified package insert of Ibuprofen given postprocedural as pain medication', 'armGroupLabels': ['Control', 'Modified Package Insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51109', 'city': 'Cologne', 'state': 'North-Rhine-Westfalia', 'country': 'Germany', 'facility': 'Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Tim Mathes, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Witten/Herdecke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '2019', 'ipdSharing': 'YES', 'description': 'Study protocol and clinical study report will be shared as supplement with the journal publication', 'accessCriteria': 'Will be published as electronic supplement with the journal publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witten/Herdecke', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Tim Mathes', 'investigatorFullName': 'Tim Mathes', 'investigatorAffiliation': 'University of Witten/Herdecke'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-06-22', 'type': 'RELEASE'}, {'date': '2023-04-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tim Mathes, Dr. Tim Mathes, University of Witten/Herdecke'}}}}