Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT06857760
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009067', 'term': 'Mouthwashes'}], 'ancestors': [{'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trials'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-22', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nausea', 'timeFrame': 'once before the application and 60, 120, 180 and 240 min. after arrival at the clinic', 'description': "Nausea level: It consists of a numeric scale. Among the numbers, ''0'' corresponds to ''no thirst/nausea'' and ''10'' corresponds to ''very much thirst/nausea''. As the number increases, nausea and thirst will be accepted as increased. There is no cut-off point."}, {'measure': 'Thirst', 'timeFrame': 'once before the application and 60, 120, 180 and 240 min. after arrival at the clinic', 'description': 'Thirst level: A minimum score of 12 and a maximum score of 60 can be obtained from the scale. The higher the score obtained from the scale, the higher the level of thirst discomfort of the patients.'}, {'measure': 'Comfort', 'timeFrame': 'once before the application and 240 min. after arrival at the clinic', 'description': 'Comfort level: The highest score that can be obtained from the scale is 192 and the lowest score is 48. A high SCS scoring indicates a high comfort level of the individual.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nausea, thirst, comfort'], 'conditions': ['Spinal Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effects of postoperative methods on nausea, thirst and comfort levels of patients undergoing spinal surgery.', 'detailedDescription': 'Within the scope of this randomized controlled study, it is aimed to evaluate the effectiveness of ice, mouthwash and menthol lozenge interventions to provide effects on postoperative nausea, thirst and comfort in patients undergoing spinal surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who underwent lumbar disc herniation (LDH) surgery\n* LDH surgery patients who recieve general anesthesia\n* The patients who were conscious\n* The duration of surgery is between 0-3 hours\n\nExclusion Criteria:\n\n* Patients who cannot understand and speak Turkish\n* Allergic patients to menthol\n* Patients who received spinal anesthesia\n* Patients with lesions on the oral mucosa and lips\n* Patients requiring intensive care after surgical intervention'}, 'identificationModule': {'nctId': 'NCT06857760', 'briefTitle': 'Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort', 'orgStudyIdInfo': {'id': 'A.30.2.ODM.0.20.08/569-677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Routine care'}, {'type': 'EXPERIMENTAL', 'label': 'Ice cube', 'interventionNames': ['Other: Ice cube']}, {'type': 'EXPERIMENTAL', 'label': 'Mouth wash', 'interventionNames': ['Other: Mouth wash']}, {'type': 'EXPERIMENTAL', 'label': 'Menthol lozenge', 'interventionNames': ['Other: Menthol lozenge']}], 'interventions': [{'name': 'Ice cube', 'type': 'OTHER', 'description': 'ıce cube', 'armGroupLabels': ['Ice cube']}, {'name': 'Mouth wash', 'type': 'OTHER', 'description': 'Mouth wash', 'armGroupLabels': ['Mouth wash']}, {'name': 'Menthol lozenge', 'type': 'OTHER', 'description': 'menthol lozenge', 'armGroupLabels': ['Menthol lozenge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amasya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Amasya Şerefeddin Sabuncuoğlu Hospital', 'geoPoint': {'lat': 40.65333, 'lon': 35.83306}}], 'centralContacts': [{'name': 'Özge İşeri Özge İşeri, Assistant Professor, PhD', 'role': 'CONTACT', 'email': 'ozgepekiniseri@gmail.com', 'phone': '03623121919'}, {'name': 'Ayşe Kale Postgraduate doctorate student, RN, MSc', 'role': 'CONTACT', 'email': 'ayse.kale@amasya.edu.tr'}], 'overallOfficials': [{'name': 'Özge İşeri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Since this is a doctoral study, the results can be shared at the end of the thesis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Ondokuz Mayıs University', 'investigatorFullName': 'Özge İşeri', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}