Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT04726605
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turkish Version of the Postoperative QoR-15
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery 15 Score', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative Quality of Recovery 15 in Turkish scale (QoR-15T)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaire Quality-of-recovery 15 (QoR-15)'], 'conditions': ['Surgery', 'Cross-Cultural Comparison', 'Postoperative Period', 'Recovery of Function']}, 'referencesModule': {'references': [{'pmid': '23411725', 'type': 'BACKGROUND', 'citation': 'Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.'}, {'pmid': '29417552', 'type': 'BACKGROUND', 'citation': 'Lyckner S, Boregard IL, Zetterlund EL, Chew MS. Validation of the Swedish version of Quality of Recovery score -15: a multicentre, cohort study. Acta Anaesthesiol Scand. 2018 Aug;62(7):893-902. doi: 10.1111/aas.13086. Epub 2018 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery after surgery. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into Turkish, and do a full psychometric evaluation of the Turkish version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, orthopedic, gynecological, urologic, eye and ENT surgery, in the University of Health Sciences, Gülhane Education and Rraining Hospital Ankara, Türkiye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted for any type of scheduled surgery with general anesthesia except heart and vascular surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged \\> 18 years old\n* underwent selective or day surgery with general anesthesia (including all surgical categories except heart and vascular surgery)\n* able to complete the QoR-15T in Turkish\n* agreed to provide written informed consent to participate\n\nExclusion Criteria:\n\n* aged \\< 18 years old\n* patients with a neuropsychiatric disturbance\n* not agreed to provide written informed consent to participate'}, 'identificationModule': {'nctId': 'NCT04726605', 'acronym': 'QoR-15T', 'briefTitle': 'Turkish Version of the Postoperative QoR-15', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}, 'officialTitle': 'Translation and Validation of the Turkish Version of the Postoperative Quality of Recovery Score QoR-15', 'orgStudyIdInfo': {'id': '2020/246'}}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Etlik', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'SBÜ Gülhane Education and Training Hospital', 'geoPoint': {'lat': 39.98205, 'lon': 32.82459}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Umut Kara', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi Gulhane Tip Fakultesi'}}}}