Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03807960
Status:
COMPLETED
Last Update Posted:
2019-07-08
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information for Patient Controlled Analgesia Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of stay hospital', 'timeFrame': 'Up to the postoperative 10 days', 'description': 'Number of the day that patients stay at hospital will be recorded.'}], 'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'At postoperative 24th hours.', 'description': 'Numeric rating scale (0 to 10) will be used for postoperative pain score'}], 'secondaryOutcomes': [{'measure': 'Postoperative analgesic consumption', 'timeFrame': 'Up to the postoperative 24th hours.', 'description': 'Total opioid dosage will be recorded'}, {'measure': 'PCA device usage', 'timeFrame': 'During postoperative 24 hours', 'description': 'The number of demand dose'}, {'measure': 'PCA device demand dose duration', 'timeFrame': 'During postoperative 24hours', 'description': "The duration of the patients' demanding dose"}, {'measure': "Patient's satisfaction", 'timeFrame': 'At the postoperative 24th hours', 'description': 'The numeric rating scale (0 to 10) will be used. In this scale 0 will be the worst, 10 will be the best satisfaction.'}, {'measure': 'The change of the postoperative pain score', 'timeFrame': 'Up to the postoperative 24th hours.', 'description': 'Numeric rating scale (0 to 10) will be used to evaluate the pain score. The change in this score during postoperative 24 hours will be calculated.(the first score will be extracted from the last score)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Care', 'Hysterectomy', 'Health Communication']}, 'descriptionModule': {'briefSummary': 'This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device', 'detailedDescription': 'Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* Elective hysterectomy\n\nExclusion Criteria:\n\n* Opioid abuse or Chronic opioid usage\n* opioid allergy\n* obesity(BMI\\>30)\n* psychiatric disease\n* more than American Anesthesiologist Score 2'}, 'identificationModule': {'nctId': 'NCT03807960', 'briefTitle': 'Information for Patient Controlled Analgesia Device', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage', 'orgStudyIdInfo': {'id': 'pcı'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'visual', 'description': 'The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook.', 'interventionNames': ['Other: video']}, {'type': 'EXPERIMENTAL', 'label': 'written', 'description': 'The written form which include the same knowledge will give to the patient for reading.', 'interventionNames': ['Other: written form']}, {'type': 'OTHER', 'label': 'control', 'description': 'The anesthesiologist will describe the PCA usage as in the routine care to the control group patients.', 'interventionNames': ['Other: routine care']}], 'interventions': [{'name': 'written form', 'type': 'OTHER', 'description': 'The written form which include PCA usage information.', 'armGroupLabels': ['written']}, {'name': 'video', 'type': 'OTHER', 'description': 'The video about PCA usage', 'armGroupLabels': ['visual']}, {'name': 'routine care', 'type': 'OTHER', 'description': 'The routine description about PCA usage', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60100', 'city': 'Tokat Province', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa University Hospital', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'overallOfficials': [{'name': 'Serkan Karaman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuğba Karaman', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor,MD', 'investigatorFullName': 'Tuğba Karaman', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}