Viewing Study NCT03768102


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Study NCT ID: NCT03768102
Status: COMPLETED
Last Update Posted: 2020-10-22
First Post: 2018-11-30
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Comparison of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measurement by the numerical rating scale', 'timeFrame': '5 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)".\n\n0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.'}, {'measure': 'Pain measurement by the numerical rating scale', 'timeFrame': '20 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.'}, {'measure': 'Pain measurement by the numerical rating scale', 'timeFrame': '40 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.'}, {'measure': 'Pain measurement by the verbal rating scale', 'timeFrame': '5 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain'}, {'measure': 'Pain measurement by the verbal rating scale', 'timeFrame': '20 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain'}, {'measure': 'Pain measurement by the verbal rating scale', 'timeFrame': '40 minutes after transferred into the postanesthesia care unit', 'description': 'Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain'}, {'measure': 'nonresponse rate of the numerical rating scale', 'timeFrame': '1 year', 'description': 'the rate of assessment failures among the total number of assessment'}, {'measure': 'nonresponse rate of the verbal rating scale', 'timeFrame': '1 year', 'description': 'the rate of assessment failures among the total number of assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Measurement', 'Acute Pain', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation is clinically important and challenging in PACU. The pain evaluation tool should be simple and easy to understand for accurate assessment. Among the most commonly used pain assessment methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating scale(VRS). These three methods have proved valid for clinical situations in many studies. VRS appears to be easier to understand than the other two methods for patients in PACU. The purpose of this study is to compare NRS and VRS in PACU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'An adult patient who has been transferred to the recovery room after receiving general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who underwent general anesthesia\n* The American Society of Anesthesiologists(ASA) physical status classification system : class 1, 2, 3\n\nExclusion Criteria:\n\n* The American Society of Anesthesiologists(ASA) physical status classification system : class 4, 5'}, 'identificationModule': {'nctId': 'NCT03768102', 'briefTitle': 'Comparison of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparative Study of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit', 'orgStudyIdInfo': {'id': 'SNUMR2-3'}}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Select', 'country': 'South Korea', 'facility': 'Jin-Tae Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}