[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616518":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"King Abdulaziz University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Device","EXPERIMENTAL","This group will experience receiving a dental injection while the operator uses a vibrating device (Vibrasthetic) to vibrate the injection site.",[13],"Device: Vibrating device",{"label":15,"type":16,"description":17,"interventionNames":18},"Manual","ACTIVE_COMPARATOR","Our study is a crossover study, so the participants will receive the dental injection while the operator manually vibrates their lip by holding the lip between their forefinger and thumb (control). The partcipants will be randomized, so phase I for the participants may be either the device or manual, and phase II will be the other method of vibration not used in phase I.",[19],"Procedure: Manual vibration",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Vibrating device","Battery powered, no need to replace vibrating head of the unit (only a plastic barrier is required to cover the device), not investigated before.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Manual vibration","The operator will hold the participant's lip between their forefinger and thumb to manually vibrate the lip and hence vibrating the injection site.",[15],[33],{"name":34,"affiliation":5,"role":35},"Mariam B Aldajani","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mariam B Aldajani, Master of Dental Science (MDS)","CONTACT","00966-567808848","maldajani@kau.edu.sa",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Ghalia Y Bhadila","00966-503637670","gbhadila@kau.edu.sa",[47],{"facility":48,"status":26,"city":49,"state":26,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"King Abdulaziz University Dental Hospital","Jeddah","Saudi Arabia","SA",{"type":53,"coordinates":54},"Point",[55,56],39.18624,21.49012,{"lat":56,"lon":55},[59,61,62,63],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":60},"mariam.aldajani@gmail.com",{"name":26,"role":39,"phone":26,"phoneExt":26,"email":60},{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":43,"role":64,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mariam Aldajani","Assistant Professor","100616518","effect-of-vibrasthetic-device-on-pain-reduction-during-local-anesthesia-in-pediatric-patients-100616518",false,"NCT07306650","Effect of Vibrasthetic Device on Pain Reduction During Local Anesthesia in Pediatric Patients","Effect of Vibrasthetic Vibration Device on Pain Reduction During Local Anesthesia in Pediatric Patients: A Randomized Clinical Study","Inclusion Criteria:\n\n* Children aged 6-14 years\n* who have previously received local anesthesia\n* and whose behavior, according to the Frankl scale, was positive or definitely positive\n* and the absence of systemic diseases or known allergies to local anesthetic agents\n\nExclusion Criteria:\n\n* Uncooperative children\n* Children with special healthcare needs\n* Children with conditions affecting pain perception",true,"ALL","6 Years","14 Years",{"count":80,"type":81},22,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this clinical trial is to test if children aged between 6 and 14 years who are receiving a dental injection will feel less pain by using a vibration device applied to the injection site during the injection compared to vibrating the lip using only the researcher's hands without using the vibration device. It will also test if this device makes them feel less anxious during the injection. The main question it aims to answer is:\n\nDoes using the Vibrasthetic device make dental injections more comfortable for children? Researchers will compare the effect of using this vibration device versus using their hands for manual vibration of the lip in the same child.\n\nParticipants will:\n\n* Experience one method of vibration during their visit to the dentist (either the vibration device or manual vibration).\n* then after 2 weeks they will go to the same dentist again and experience the other method of vibration.\n* Receive the dental treatment they need in both visits. Participants will be asked to rate the pain they felt after the injection. This will be done by the participants choosing one of 6 pictures we will show them. Each picture explains the level of the pain they felt, and each picture has a score. We will score the pain the participants felt by looking at which picture they chose to describe their pain from the injection.",[87,88],"Healthy","Behavior Management",[90,91,92,93,94],"Vibrasthetic","Vibration","child behavior management","local anesthesia","pediatric dentistry","NOT_YET_RECRUITING","2025-12-28",{"date":98,"type":99},"2026-01-02","ACTUAL",{"date":101,"type":81},"2025-12-26",{"date":103,"type":81},"2026-06",{"name":5,"class":6},1]