Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02541357
Status:
TERMINATED
Last Update Posted:
2017-05-25
First Post:
2015-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Recruitment insufficient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative anxiety', 'timeFrame': 'day of surgery', 'description': 'State Anxiety (STAI-S) (Spielberger 1970)'}, {'measure': 'postoperative pain intensity', 'timeFrame': 'day after the surgery, before meditation', 'description': 'numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving'}], 'secondaryOutcomes': [{'measure': 'preoperative anxiety', 'timeFrame': 'day of surgery', 'description': 'Trait Anxiety (STAI-T) (Spielberger 1970)'}, {'measure': 'preoperative anxiety', 'timeFrame': 'day of surgery', 'description': 'Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)'}, {'measure': 'preoperative anxiety', 'timeFrame': 'day of surgery', 'description': 'Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)'}, {'measure': 'postoperative disability', 'timeFrame': 'day after surgery', 'description': 'interference of pain with movement, coughing, waking up at night and disturbed mood'}, {'measure': 'postoperative disability', 'timeFrame': '2 days after surgery', 'description': 'interference of pain with movement, coughing, waking up at night and disturbed mood'}, {'measure': 'postoperative disability', 'timeFrame': '10 days after surgery', 'description': 'interference of pain with movement, coughing, waking up at night and disturbed mood'}, {'measure': 'postoperative fatigue', 'timeFrame': 'day after surgery', 'description': 'Fatigue measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative fatigue', 'timeFrame': '2 days after surgery', 'description': 'Fatigue measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative fatigue', 'timeFrame': '10 days after surgery', 'description': 'Fatigue measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative nausea', 'timeFrame': 'Day after surgery', 'description': 'Nausea measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative nausea', 'timeFrame': '2 days after surgery', 'description': 'Nausea measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative nausea', 'timeFrame': '10 days after surgery', 'description': 'Nausea measured by 0-10 Numeric Rating Scale'}, {'measure': 'postoperative complications', 'timeFrame': '10 days after surgery', 'description': 'Number of Participants With Treatment-Related Adverse Events'}, {'measure': 'Satisfaction with care', 'timeFrame': '10 days after surgery', 'description': 'Satisfaction with the operation, the hospital care on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)'}, {'measure': 'Satisfaction with interventions', 'timeFrame': '10 days after surgery', 'description': 'Satisfaction with interventions on a visual analog scale each from 0 (not satisfied) to 100 (most satisfied)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal Surgery'], 'conditions': ['Gastrointestinal Diseases']}, 'descriptionModule': {'briefSummary': 'This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing colorectal surgery.', 'detailedDescription': 'A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore this study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing colorectal surgery using a factorial design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referral for colorectal surgery\n* preoperative anxiety at least 4/10 points on a numeric rating scale\n* physical and mental capability to participant\n* written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* known malignoma\n* severe comorbidity\n* severe psychological disorders\n* immunosuppression\n* coagulation disorders'}, 'identificationModule': {'nctId': 'NCT02541357', 'acronym': 'MBM_Colo', 'briefTitle': 'Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Colorectal Surgery - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '15-6459 MBM Colorectal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Does not receive a specific study intervention'}, {'type': 'EXPERIMENTAL', 'label': 'preoperative relaxation program', 'description': 'preoperative relaxation program', 'interventionNames': ['Behavioral: relaxation program']}, {'type': 'EXPERIMENTAL', 'label': 'preoperative surgery education', 'description': 'single education unit to understand the complete surgical procedures', 'interventionNames': ['Behavioral: surgery education']}, {'type': 'EXPERIMENTAL', 'label': 'preop relaxation and surgery education', 'description': 'preoperative relaxation program AND single education unit', 'interventionNames': ['Behavioral: relaxation program', 'Behavioral: surgery education']}], 'interventions': [{'name': 'relaxation program', 'type': 'BEHAVIORAL', 'description': 'relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises\n\n1 week program, one introductory session and daily home practice', 'armGroupLabels': ['preop relaxation and surgery education', 'preoperative relaxation program']}, {'name': 'surgery education', 'type': 'BEHAVIORAL', 'description': 'intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery\n\n1 single unit in the week before the surgery', 'armGroupLabels': ['preop relaxation and surgery education', 'preoperative surgery education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47228', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}], 'overallOfficials': [{'name': 'Gustav Dobos, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study has been terminated'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Gustav Dobos', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}