Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-09 @ 6:24 AM
Study NCT ID:
NCT03872934
Status:
UNKNOWN
Last Update Posted:
2019-07-15
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Music Types on Implant Surgery Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Corah's dental anxiety scale", 'timeFrame': 'six month', 'description': 'the type of music that reduces anxiety in patients undergoing implant surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety, Dental']}, 'referencesModule': {'references': [{'pmid': '30931796', 'type': 'RESULT', 'citation': 'Miyata K, Odanaka H, Nitta Y, Shimoji S, Kanehira T, Kawanami M, Fujisawa T. Music before Dental Surgery Suppresses Sympathetic Activity Derived from Preoperative Anxiety: A Randomized Controlled Trial. JDR Clin Trans Res. 2016 Jul;1(2):153-162. doi: 10.1177/2380084416650613.'}, {'pmid': '24029113', 'type': 'RESULT', 'citation': 'Bodner E, Iancu I. Recalling the threat: dental anxiety in patients waiting for dental surgery. Isr J Psychiatry Relat Sci. 2013;50(1):61-6.'}, {'pmid': '25200448', 'type': 'RESULT', 'citation': 'Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.'}, {'type': 'RESULT', 'citation': 'Wright H. The Correlation of Classical, Jazz, and Pop Music to a Reduction of Dental Anxiety Experienced by Adult Patients. 2018.'}], 'seeAlsoLinks': [{'url': 'http://www.reference.md/files/D016/mD016854.html', 'label': 'Encyclopedia of Medical Concepts. Reference. MD website.'}]}, 'descriptionModule': {'briefSummary': 'A general term, dental anxiety, is defined as fear or an abnormal concern to visit the dentist for unwanted concerns about preventive care and dental procedures. anxiety; dental examinations or treatment can be prevented or postponed.\n\nThis delay in dentistry typically leads to much more serious dental problems, often leading to more expensive, more invasive and possibly emergency treatment. Therefore, reducing anxiety is important both in terms of patient, physician and cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eighty patients aged 40-70 years will undergo elective implant surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Will undergo elective implant surgery,\n* between 40-70 years\n\nExclusion Criteria:\n\n* Who does not agree to participate in the study,\n* Under 40, over 70 years,\n* Patients with ear disorders (ie, not suitable for musical intervention),\n* arrhythmia\n* patients with physical condition III or higher (American Society of Anesthesiologists)'}, 'identificationModule': {'nctId': 'NCT03872934', 'briefTitle': 'Effect of Different Music Types on Implant Surgery Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'Effect of Different Music Types on Implant Surgery Anxiety - Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EBYU 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Turkish music group', 'description': 'Turkish music group (Saba or rast makam)', 'interventionNames': ['Behavioral: implant anxiety']}, {'label': 'classical western music', 'description': 'classical western music (vivaldi)', 'interventionNames': ['Behavioral: implant anxiety']}, {'label': 'soft rock music', 'description': 'soft rock music (elvis)', 'interventionNames': ['Behavioral: implant anxiety']}, {'label': 'control group (group not listening music)', 'description': 'control', 'interventionNames': ['Behavioral: implant anxiety']}], 'interventions': [{'name': 'implant anxiety', 'type': 'BEHAVIORAL', 'description': 'to determine the type of music that reduces anxiety in patients undergoing implant surgery.', 'armGroupLabels': ['Turkish music group', 'classical western music', 'control group (group not listening music)', 'soft rock music']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ilke kupeli', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}], 'overallOfficials': [{'name': 'ilke kupeli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erzincan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assist. prof.', 'investigatorFullName': 'ILKE KUPELI', 'investigatorAffiliation': 'Erzincan University'}}}}