Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:23 AM
Study NCT ID:
NCT07484334
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The operating clinician/investigator was blinded to group assignment during the surgical procedure. Participants were aware of the type of preoperative information they received; therefore, participant masking was not possible.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned in parallel to 1 of 3 groups: standard verbal information, real surgical video information, or 3D animation video information before impacted mandibular third molar surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure (SBP)', 'timeFrame': 'Preoperative, intraoperative, and 15 minutes postoperatively', 'description': 'Systolic blood pressure measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).'}, {'measure': 'Change in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Preoperative, during surgery, and 15 minutes after surgery', 'description': 'Diastolic blood pressure measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).'}, {'measure': 'Change in Heart Rate (HR)', 'timeFrame': 'Preoperative, during surgery, and 15 minutes after surgery', 'description': 'Heart rate measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).'}, {'measure': 'Change in Oxygen Saturation (SpO₂)', 'timeFrame': 'Preoperative, intraoperative, and 15 minutes postoperatively', 'description': 'Peripheral oxygen saturation measured at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).'}], 'secondaryOutcomes': [{'measure': 'Modified Dental Fear Survey (MDFS) Score', 'timeFrame': 'Immediately after preoperative information, before surgery', 'description': 'Dental fear assessed using the Modified Dental Fear Survey after the assigned preoperative information intervention and before surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Information Video', 'Dental Anxiety', 'Impacted Third Molar', 'Vital Signs'], 'conditions': ['Impacted Mandibular Third Molar Extraction', 'Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.', 'detailedDescription': "Impacted mandibular third molar surgery is a common oral surgical procedure that is frequently associated with patient stress, fear, and physiologic fluctuations during the perioperative period. In addition to subjective anxiety, these stress responses may be reflected in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation.\n\nThis randomized controlled study was designed to investigate whether physician-guided visual information can improve perioperative hemodynamic stability compared with standard verbal information alone. Participants undergoing impacted mandibular third molar surgery are assigned to one of three preoperative information approaches: standard verbal information, real surgical video information, or 3D animation video information.\n\nThe primary objective is to compare the effects of these information modalities on perioperative hemodynamic responses measured at predefined time points, including baseline, after local anesthesia, during tooth luxation, after suturing, and during the early recovery period. The secondary objective is to evaluate the effect of these information methods on dental fear using a validated psychometric scale.\n\nThe study is based on the hypothesis that visually supported preoperative information, when delivered in a structured and physician-guided manner, may reduce stress-related physiologic fluctuations during surgery and may also influence patients' self-reported dental fear. By comparing verbal, real video, and animation-based information methods, the study aims to clarify whether visual information contributes to better physiologic regulation and patient preparation before third molar surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 50 years\n\nASA physical status I or II\n\nRadiographic evidence of an impacted mandibular third molar classified as Pell-Gregory Class I or II and Position A or B\n\nPresence of mandibular third molar (tooth 38 or 48) in a vertical or mesioangular position according to Winter's classification\n\nIndication for impacted mandibular third molar extraction\n\nWillingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Active smoking or alcohol consumption\n\nBleeding/coagulation disorders or any systemic disease/medication use that could impair wound healing\n\nPregnancy or lactation\n\nLocal pathologies associated with the impacted tooth, such as cysts or tumors\n\nHistory of severe anxiety disorder or known psychiatric illness\n\nKnown allergy to local anesthetics or planned postoperative medications\n\nPresence of uncontrolled active periodontal disease\n\nInability or unwillingness to comply with follow-up procedures"}, 'identificationModule': {'nctId': 'NCT07484334', 'briefTitle': 'Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University'}, 'officialTitle': 'The Effect of Preoperative Surgical Information Videos on Hemodynamic Parameters and Dental Anxiety in Impacted Mandibular Third Molar Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1462'}, 'secondaryIdInfos': [{'id': '2025/225', 'type': 'OTHER', 'domain': 'Non-Interventional Clinical Research Ethics Committee of Recep Tayyip Erdoğan University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Verbal Information', 'description': 'Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.', 'interventionNames': ['Behavioral: Standard Verbal Information']}, {'type': 'EXPERIMENTAL', 'label': 'Real Surgical Video Information', 'description': 'Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.', 'interventionNames': ['Behavioral: Real Surgical Video Information']}, {'type': 'EXPERIMENTAL', 'label': '3D Animation Video Information', 'description': 'Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.', 'interventionNames': ['Behavioral: 3D Animation Video Information']}], 'interventions': [{'name': 'Standard Verbal Information', 'type': 'BEHAVIORAL', 'description': 'Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.', 'armGroupLabels': ['Standard Verbal Information']}, {'name': 'Real Surgical Video Information', 'type': 'BEHAVIORAL', 'description': 'Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.', 'armGroupLabels': ['Real Surgical Video Information']}, {'name': '3D Animation Video Information', 'type': 'BEHAVIORAL', 'description': 'Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.', 'armGroupLabels': ['3D Animation Video Information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53200', 'city': 'Rize', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Recep Tayyip Erdogan University Faculty of Dentistry', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study was conducted at a single center with a limited sample size, and the dataset contains potentially identifiable clinical information. No formal plan for external IPD sharing has been established.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry', 'investigatorFullName': 'Emre Can ÇIRALIK', 'investigatorAffiliation': 'Recep Tayyip Erdogan University'}}}}