Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT07259551
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Palming Technique on Preoperative Anxiety and Hemodynamic Responses in Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Preoperative Anxiety Score (State-Trait Anxiety Inventory - STAI-State)', 'timeFrame': 'Baseline (T1) and 15 minutes after intervention (T2)', 'description': 'Baseline (TPreoperative anxiety will be assessed using the State-Trait Anxiety Inventory - State (STAI-State) scale (range: 20-80; higher scores indicate higher anxiety). The primary outcome is the change in STAI-State score from baseline (T1) to 15 minutes after the palming technique (T2).1) and 15 minutes after intervention (T2)'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Baseline (T1) and 15 minutes after intervention (T2)', 'description': 'Change in heart rate (beats per minute) between baseline (T1) and 15 minutes after the palming technique (T2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodynamics', 'intubation', 'preoperative anxiety', 'relaxation techniques', 'thyroidectomy'], 'conditions': ['Preoperative Anxiety and Associated Hemodynamic Changes']}, 'referencesModule': {'references': [{'pmid': '35480569', 'type': 'BACKGROUND', 'citation': 'Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'https://en.wikipedia.org/w/index.php?title=Bates_method&oldid=1289654741', 'label': 'Bates method. In: Wikipedia \\[Internet\\]. 2025 \\[cited 2025 May 11\\].'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy.\n\nPrimary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II\n\nMethods:\n\nPatients were divided into two groups using a sealed envelope method:\n\nGroup P: Patients who received the palm-based technique Group N: Control group without intervention\n\nWhen admitted to the preoperative waiting room (T1), all patients:\n\nBaseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention.\n\nThe same parameters were measured again 15 minutes later (T2).\n\nAfter transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times:\n\nPre-intubation (T3)\n\n1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique Sample Size:Total: 80 patients', 'detailedDescription': 'Purpose of the Observational Study: The purpose of this observational study was to evaluate the effects of the palmar technique on preoperative anxiety, hemodynamic parameters, and intubation-related hemodynamic responses in patients undergoing thyroidectomy.\n\nPrimary Research Question: Does the palmar technique applied preoperatively reduce preoperative anxiety and associated hemodynamic changes in thyroidectomy patients? Study Design: Type: Prospective, single-blind, observational study Location: A single-center tertiary care hospital in Turkey Sample: 80 patients aged 18-65, ASA I-II\n\nMethods:\n\nPatients were divided into two groups using a sealed envelope method:\n\nGroup P: Patients who received the palm-based technique Group N: Control group without intervention\n\nWhen admitted to the preoperative waiting room (T1), all patients:\n\nBaseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention.\n\nThe same parameters were measured again 15 minutes later (T2).\n\nAfter transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times:\n\nPre-intubation (T3)\n\n1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique Sample Size:Total: 80 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of adult patients scheduled to undergo thyroidectomy at a tertiary care hospital in Türkiye. A total of 80 patients aged 18-65 years and classified as ASA I-II according to the American Society of Anesthesiologists physical status classification were included. All participants were thoroughly informed about the study procedures and provided written informed consent. Eligible patients had no active psychiatric or neurological disorders, no history of glaucoma, and no prior ophthalmic surgery. Following randomization, patients were assigned to either the palming group (n = 40) or the control group (n = 40).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 years\n* Patients classified as ASA I-II\n* Patients scheduled for thyroid surgery\n* Patients without a history of glaucoma\n* Patients without active psychiatric or neurological disease\n* Patients who were informed about the study and provided written informed consent\n\nExclusion Criteria:\n\n* Patients with a diagnosed psychiatric disorder\n* Patients using sedatives, antidepressants, or antiepileptic medications\n* Patients with impaired cooperation, comprehension, vision, or hearing\n* Patients with a history of ophthalmic surgery\n* Patients classified as ASA III or higher'}, 'identificationModule': {'nctId': 'NCT07259551', 'briefTitle': 'Effect of the Palming Technique on Preoperative Anxiety and Hemodynamic Responses in Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Effect of the Palming Technique on Preoperative Anxiety and Hemodynamic Responses in Thyroid Surgery', 'orgStudyIdInfo': {'id': 'The Palming Technique'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group P', 'description': 'Patients who received the palm-based technique', 'interventionNames': ['Behavioral: Group P']}, {'label': 'Group N', 'description': 'Control group without intervention'}], 'interventions': [{'name': 'Group P', 'type': 'BEHAVIORAL', 'description': 'When admitted to the preoperative waiting room (T1), all patients:\n\nBaseline vital signs (SpO₂, heart rate, blood pressure) State-Trait Anxiety Inventory (STAI) scores were recorded. Patients in Group P received the palm-based technique; Group N received no intervention.\n\nThe same parameters were measured again 15 minutes later (T2).\n\nAfter transfer to the operating room, standard monitoring was performed, and hemodynamic data were recorded at the following times:\n\nPre-intubation (T3)\n\n1 min (T4), 3 min (T5), 5 min (T6), and 10 min (T7) after intubation Main Outcome Measures: Changes in preoperative anxiety level Changes in hemodynamic parameters after the palmar technique', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65080', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yüzüncü Yıl Universitesi', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Nureddin Yuzkat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available to other researchers due to confidentiality considerations and because data sharing was not included in the informed consent obtained from participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Nureddin YUZKAT', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}