Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04009018
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2019-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058926', 'term': 'Intraoperative Awareness'}], 'ancestors': [{'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'postoperative 48 hours', 'description': 'Perioperative Satisfaction Scale in Regional Anesthesia will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scale', 'validity', 'reliability'], 'conditions': ['Scales, Repression-Sensitization', 'Anesthesia Awareness']}, 'referencesModule': {'references': [{'pmid': '21455058', 'type': 'BACKGROUND', 'citation': 'Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.'}, {'pmid': '23221859', 'type': 'RESULT', 'citation': 'Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23221859', 'label': 'Original validation study of Perioperative Satisfaction Scale in Regional Anesthesia'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.', 'detailedDescription': 'The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia. An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer to participate in the research\n* Participants are over 18 years of age\n* Provided regional anesthesia\n* Postoperative second day\n* No cognitive problems in self-expression\n\nExclusion Criteria:\n\n* Lack of Turkish literacy\n* Use of anesthesia technique other than regional anesthesia'}, 'identificationModule': {'nctId': 'NCT04009018', 'briefTitle': 'Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties', 'orgStudyIdInfo': {'id': 'Regional-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Psycometric analyses', 'description': 'It will be a validation study of the Perioperative Satisfaction Scale in Regional Anesthesia. This study is not experimental research. This is a psychometric assessment study of a questionnaire and data will collect pencil-paper survey and face to face from the patients who will get regional anesthesia in the postoperative second day.', 'interventionNames': ['Other: Perioperative Satisfaction Scale in Regional Anesthesia']}], 'interventions': [{'name': 'Perioperative Satisfaction Scale in Regional Anesthesia', 'type': 'OTHER', 'otherNames': ['Measurement tool (Questionnaire)'], 'description': 'This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.', 'armGroupLabels': ['Psycometric analyses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Kahramanmaraş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Omer Faruk Boran, MD', 'role': 'CONTACT', 'email': 'ofboran@ksu.edu.tr', 'phone': '05052855844'}], 'facility': 'Kahramanmaras Sutcu Imam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'centralContacts': [{'name': 'Omer Faruk Boran, MD', 'role': 'CONTACT', 'email': 'ofboran@ksu.edu.tr', 'phone': '05052855844'}], 'overallOfficials': [{'name': 'Fatih Mehmet Yazar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kahramanmaras Sutcu Imam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ömer Faruk Boran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ömer Faruk Boran', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}