Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-03 @ 5:53 AM
Study NCT ID:
NCT04829266
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Simulations and Early Mobilization of Patients After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'willingness to verticalize', 'timeFrame': 'Immediately after a single mental simulation', 'description': 'Percentage of women who were willing to verticalize after listening to the recording. Assessed on a on a six-point scale.'}, {'measure': 'verticalization', 'timeFrame': 'Immediately after a single mental simulation', 'description': 'Percentage of the success of verticalization after listening to the recording.'}, {'measure': 'duration of the first mobilization', 'timeFrame': 'Immediately after a single mental simulation', 'description': "Time form the start of the measurement was set at getting out of bed from a sitting position, and the end of the measurement was set at the patient's return to bed."}], 'secondaryOutcomes': [{'measure': 'pain level', 'timeFrame': '3 time points (before and immediately after a single mental simulation, and immediately after verticalization.', 'description': 'The average pain she experienced during upright standing. Measured with a 10-point numerical rating scale.'}, {'measure': 'anxiety', 'timeFrame': 'upon arrival at the recovery room, before and immediately after a single mental simulation.', 'description': 'Measured with a 10-point numerical rating scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental simulation', 'anxiety', 'verticalization', 'obstetrics', 'cesarean section', 'post-operative care'], 'conditions': ['Anxiety', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '34811410', 'type': 'DERIVED', 'citation': 'Prokopowicz A, Byrka K. Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial. Sci Rep. 2021 Nov 22;11(1):22634. doi: 10.1038/s41598-021-02036-1.'}]}, 'descriptionModule': {'briefSummary': 'Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be qualified to and undergoing delivery using Cesarean section,\n* must be undergoing conduction of anesthesia during Cesarean section,\n* must be undergoing the analgesic therapy in the postoperative period,\n* must be qualified to mobilization by the medical staff,\n* must be fluent in Polish in speaking and writing.\n\nExclusion Criteria:\n\n* any orthopedic dysfunction,\n* any neurological dysfunction,\n* any psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT04829266', 'briefTitle': 'Mental Simulations and Early Mobilization of Patients After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Effect of Mental Simulations on the Early Mobilization of Patients After Cesarean Section', 'orgStudyIdInfo': {'id': '05P/12-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'process simulation group', 'description': 'an experimental group with process simulation with elements of relaxation', 'interventionNames': ['Behavioral: mental simulation']}, {'type': 'EXPERIMENTAL', 'label': 'outcome simulation group', 'description': 'an experimental group with outcome simulation with elements of relaxation', 'interventionNames': ['Behavioral: mental simulation']}, {'type': 'OTHER', 'label': 'control group', 'description': 'a control group with no process and outcome simulations, but with elements of relaxation', 'interventionNames': ['Behavioral: mental simulation']}], 'interventions': [{'name': 'mental simulation', 'type': 'BEHAVIORAL', 'otherNames': ['The recording of the process simulation included the order to imagine subsequent elements of the process of mobilization.', 'The recording of the outcome simulation included an optimistic vision of returning to health and fitness.', 'A fragment of the book "Little Prince" by Antoine de Saint-Exupéry, including an order to imagine the elements of the world as seen through the eyes of the main character'], 'description': 'Audio recordings with a mental simulation. The women listened to the text using headphones about 10-15 min before verticalization (5 h after arrival in the postoperative room, about 6 h after anesthesia). In each group, the mental training lasted for about 10 min.', 'armGroupLabels': ['control group', 'outcome simulation group', 'process simulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': '2nd Chair and Clinic of Gynecology and Obstetrics, Jan Mikulicz-Radecki University Teaching Hospital in Wrocław, Wrocław, Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Anna Prokopowicz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Applied Obstetrics, Faculty of Health Sciences, Wroclaw Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Prokopowicz, MSc', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}