[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639520":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":50,"overallOfficials":60,"centralContacts":67,"locations":73,"responsibleParty":88,"collaborators":30,"id":92,"slug":30,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":30,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":30,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":30,"overallStatus":111,"whyStopped":30,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":30},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Dental anxiety assessment using Venham's Clinical Anxiety Scale","VCAS rates the child's anxiety into 6 categories with scores ranging from 0 to 5. A score of 0 means low anxiety and a score of 5 refers to debilitating anxiety so much so that the child is out of contact with the reality of the threat and the requirement of physical restraint. The operator will assign a score to each child based on the child's response by analvsis of the recorded videotape.","At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)",{"measure":14,"description":15,"timeFrame":16},"Dental anxiety assessment using Pulse rate","The pulse rate will be measured using a pulse oximeter","At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)",{"measure":18,"description":19,"timeFrame":20},"Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale","It evaluates 5 behavioral categories namely Face, Legs, Activity, Cry, Consolability. Each category is scored 0-2, yielding a total pain score of 0-10 (higher = more severe pain). The operator will assign a score to each category based on the child's response by analysis of the recorded videotape.","During injection - During extraction",[22,26],{"measure":23,"description":24,"timeFrame":25},"Dental anxiety assessment using Facial Image Scale","The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.","At baseline (preoperatively) - Immediately after extraction (postoperatively)",{"measure":27,"description":28,"timeFrame":29},"Dental pain assessment using Faces Pain Scale - Revised","The Faces pain scale - Revised features 6 gender neutral faces arranged horizontally, showing increasing levels of pain from \"no pain\" (leftmost face, scored as 0) to \"very much pain\" (rightmost face, scored as 10). Children will be asked to point to the face that best matches their pain level.","Immediately after injection - Immediately after extraction",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"brainwave entrainment group","EXPERIMENTAL","Children allocated to this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort.",[43],"Device: Brainwave entrainment",{"label":45,"type":46,"description":47,"interventionNames":48},"Basic behavior management technique","ACTIVE_COMPARATOR","Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).",[49],"Behavioral: Basic behavioral management technique",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":30},"DEVICE","Brainwave entrainment","Children allocated ot this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort.",[39],{"type":57,"name":58,"description":47,"armGroupLabels":59,"otherNames":30},"BEHAVIORAL","Basic behavioral management technique",[45],[61,64],{"name":62,"affiliation":5,"role":63},"Abdelwahab Samaha, PHD","STUDY_DIRECTOR",{"name":65,"affiliation":5,"role":66},"Nadia Aziz Wahba, PHD","STUDY_CHAIR",[68],{"name":69,"role":70,"phone":71,"phoneExt":30,"email":72},"Malak Hazem Zaghloul, BDS","CONTACT","+201009793275","m.hazem161179.na@alexu.edu.eg",[74],{"facility":75,"status":30,"city":76,"state":30,"zip":30,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Faculty of dentistry Alexandria university","Alexandria","Egypt","EG",{"type":80,"coordinates":81},"Point",[82,83],29.91582,31.20176,{"lat":83,"lon":82},[86],{"name":69,"role":70,"phone":71,"phoneExt":30,"email":87},"malakhazem1998@gmail.com",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Malak Hazem","Clinical instructor of Pediatric Dentistry","100639520",false,"NCT07617662","Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.","Effectiveness of Brainwave Entrainment on Anxiety and Pain Perception in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)","Inclusion Criteria:\n\n* Participants enrolled in the study will be selected after fulfilling the following inclusion criteria:\n\n  1. Healthy six to nine years old.\n  2. Frankl behavioural rating score 2 during preoperative assessment\n  3. Bilateral mandibular primary molars indicated for extraction.\n  4. Written guardian consent.\n\nExclusion Criteria:\n\n* Children with:\n\n  1. Physical disabilities or psychiatric disorders\n  2. Epilepsy.\n  3. Visual or hearing disabilities\n  4. On photophobia inducing or hearing altering medications.\n  5. Hypersensitivity to local anesthetic drugs used.","ALL","6 Years","9 Years",{"count":102,"type":103},34,"ESTIMATED","INTERVENTIONAL",[106],"NA","Pediatric dental anxiety and pain management present significant clinical challenges during routine treatment. While conventional behavior management techniques exist, their inconsistent effectiveness necessitates the continuous search for alternative solutions. Brainwave entrainment (BWE) , a novel approach using audiovisual stimuli to induce relaxing alpha waves (8-12 Hz) , shows promise in anxiety and pain management. However, its application in pediatric dentistry remains insufficiently explored, particularly for invasive dental procedures.",[109,110],"Pediatric Dental Anxiety","Pediatric Dental Pain","NOT_YET_RECRUITING","2026-05-29",{"date":114,"type":115},"2026-06-01","ACTUAL",{"date":117,"type":103},"2026-05",{"date":119,"type":103},"2026-10",{"name":5,"class":6},1]