Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 5:40 AM
Study NCT ID:
NCT06811051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-06
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-02-02', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain score', 'timeFrame': 'Pain was assessed at 4 time points, immediately before the first application (baseline) and 30 minutes after application of each of the three lozenges (T1, T2, T3).', 'description': 'Sore throat pain will be measured by VAS score: zero mean NO PAIN, 10 means unsupportable pain.'}, {'measure': 'sore throat', 'timeFrame': '60 minutes after extubation', 'description': 'VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".'}], 'secondaryOutcomes': [{'measure': 'Sore throat', 'timeFrame': '90 minutes after extubation', 'description': 'VAS is used to make measurable some values that cannot be measured numerically, evaluated by individuals by marking them on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end of which indicates that the individual is "very bad".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sore throat', 'lozenge', 'postoperative'], 'conditions': ['Sore Throat']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/?term=sore+throat+after+extubation&filter=datesearch.y_5', 'label': 'sore throat after extubation'}]}, 'descriptionModule': {'briefSummary': 'In patients undergoing surgical intervention, endotracheal intubation, which is a part of the anesthesia procedure, can cause postoperative sore throat in patients. This situation causes difficulty in swallowing, inadequate nutrition and fluid intake, and prolongs the recovery process. In addition, sore throat is defined as a source of physical stress, which can lead to an increase in the incidence of postoperative morbidity and a decrease in patient satisfaction. This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat after surgery. Our aim was to provide evidence on the effectiveness of simple, low-cost menthol and clove oil lozenges in reducing sore throat after extubation, thus helping the patient recover.', 'detailedDescription': 'This study aimed to investigate the effect of menthol and clove oil lozenges on sore throat in patients after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65. Having had abdominal surgery. Being extubated within the first 8 hours after surgery. ASA class I-III. Mallampati class I-II. Glasgow Coma Scale (GCS) score 15\n\nExclusion Criteria:\n\n* History of allergies.\n\n * Severe nausea and vomiting.\n * Being extubated after the first 8 hours after surgery.\n * Communication disorders\n * Mallampati class III-IV.\n * Glasgow Coma Scale (GCS) score \\<15'}, 'identificationModule': {'nctId': 'NCT06811051', 'briefTitle': 'Effect of Clove Oil and Menthol Lozenges on Post-extubation Sore Throat', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'Effects of Clove Oil and Menthol-containing Lozenges in Preventing Post-extubation Sore Throat in Patients Undergoing Surgical Intervention', 'orgStudyIdInfo': {'id': 'CToprak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menthol Group Patients', 'description': 'Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.', 'interventionNames': ['Biological: Menthol lozenge']}, {'type': 'EXPERIMENTAL', 'label': 'Clove lozenge group', 'description': 'Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.', 'interventionNames': ['Biological: Clove lozenge']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.', 'interventionNames': ['Other: None-placebo']}], 'interventions': [{'name': 'Menthol lozenge', 'type': 'BIOLOGICAL', 'description': 'Patients in the menthol group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.', 'armGroupLabels': ['Menthol Group Patients']}, {'name': 'Clove lozenge', 'type': 'BIOLOGICAL', 'description': 'Patients in the clove group will fill out the Patient introduction form, patient follow-up form, and numerical pain scale just before the first application. After 60 minutes after extubation, they will be asked to take the lozenge into their mouth without chewing or swallowing it and suck it, and the patient will be monitored until the lozenge is completely dissolved. After the first lozenge is finished, the patient follow-up form and numerical pain scale will be filled out. The second lozenge will be sucked 90 minutes after extubation. The third lozenge will be sucked 120 minutes after extubation and the patient follow-up form and numerical pain scale will be filled out.', 'armGroupLabels': ['Clove lozenge group']}, {'name': 'None-placebo', 'type': 'OTHER', 'description': 'Before routine clinical procedures after surgery, the patients in the control group will fill out the Patient introduction form, Patient follow-up form, and Numerical pain scale. After 60 minutes after extubation; clinical procedures do not include any procedures or interventions and the patient follow-up form and Numerical pain scale will be evaluated. After 120 minutes after extubation; the patient follow-up form and numerical pain scale will be evaluated.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Kağıthane', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlas University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Atlas University', 'investigatorFullName': 'Cagla Toprak', 'investigatorAffiliation': 'Atlas University'}}}}