[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719205":3,"trial-entities:NCT07719205":96,"trial-summary:NCT07719205":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":62,"locations":64,"central_contacts":92,"overall_officials":93,"references":94,"see_also_links":95},"NCT07719205","HS-25-00212","Tactile Pre-Visit Imagery","Tactile Pre-Visit Imagery Effect on Behavior of Children During Dental Procedures","RECRUITING","2028-06","2026-07","2026-07-22","2026-01-15","University of Southern California","OTHER",false,"In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown.\n\nStudy Objective\u002FPurpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet.",null,[19,20],"Dental Anxiety in Children","Behavior Change",[],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},100,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Tactile Previsit Imagery Booklet","Physical Booklet that walks patient through all materials used during the dental treatmne and contains physical items that are going to be used so that patient can touch and feel.",[34],"Tactile Previsit Imagery",[36],{"measure":37,"description":38,"timeFrame":39},"Dental Anxiety","Change in dental anxiety before and after treatment. The Venham Picture test is used to measure the child's anxiety. The scores from the Venham Picture test will be compared between pre- and post- treatment to determine changes in dental anxiety.","At baseline (pre-intervention) and immediately after treatment (post-intervention)",[41],{"measure":42,"description":43,"timeFrame":44},"Change in Behavior","Change in behavior\u002Fcooperation of patient before and after treatment. Child's behavior will be measured using the Frankl Behavior score. The Frankl score will be recorded pre- and post-treatment to determine a change in behavior.","At baseline (preintervention) and immediately after treatment (post-intervention)","ALL","4 Years","10 Years",true,{"inclusion":50,"exclusion":56,"raw_text":61},[51,52,53,54,55],"Children aged 4-10 years","ASA I or II","Patients who have NOT had dental treatment before","Patients needing at least ONE composite filling or stainless steel crown \\[CP1\\] with nitrous oxide and local anesthesia (composite filling must be done at the first treatment visit)","Parents and children must speak English or Spanish",[57,58,59,60],"Children with developmental delays or cognitive impairments that may impact their ability to participate in pre-visit imagery activities","Patients with visual or tactile disabilities associated for a particular medical condition or as reported on their medical history form","Patients who refuse to wear nitrous hood","Emergency dental appointments","Inclusion Criteria:\n\n* Children aged 4-10 years\n* ASA I or II\n* Patients who have NOT had dental treatment before\n* Patients needing at least ONE composite filling or stainless steel crown \\[CP1\\] with nitrous oxide and local anesthesia (composite filling must be done at the first treatment visit)\n* Parents and children must speak English or Spanish\n\nExclusion Criteria:\n\n* Children with developmental delays or cognitive impairments that may impact their ability to participate in pre-visit imagery activities\n* Patients with visual or tactile disabilities associated for a particular medical condition or as reported on their medical history form\n* Patients who refuse to wear nitrous hood\n* Emergency dental appointments",[63],"CHILD",[65,80],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"USC Herman Ostrow School of Dentistry - Pediatric Dental Clinic","Los Angeles","California","90089","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Catherine Pham","CONTACT","213-740-0412","cmpham@usc.edu",{"lat":78,"lon":79},34.05223,-118.24368,{"facility":81,"status":8,"city":82,"state":68,"zip":83,"country":70,"contacts":84,"geoPoint":89},"Altamed Dental Clinic","Santa Ana","92704",[85],{"name":86,"role":74,"phone":87,"email":88},"Alyssa Nowlen","888-499-9303","annowlen@usc.edu",{"lat":90,"lon":91},33.74557,-117.86783,[],[],[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Fear of dentist",[],{"nct_id":4,"found":48,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study, meaning participants will receive a specific intervention (the booklet). It aims to enroll 100 children.","completed","Tactile Pre-Visit Imagery for Children's Dental Anxiety","This study is looking at whether a special booklet called a \"Tactile Pre-Visit Imagery Booklet\" can help reduce dental anxiety and fear in children aged 4 to 10 years old who are having their first dental procedure. The booklet lets children touch and feel the actual dental tools that will be used during their visit. Researchers want to see if this helps children feel less anxious and behave better during their dental treatment. To join, your child must be between 4 and 10, healthy (ASA I or II), and have never had dental treatment before. They also need at least one composite filling or stainless steel crown with nitrous oxide (laughing gas) and local anesthesia (numbing medicine). Both you and your child must speak English or Spanish. The study is currently unclear on its recruitment status and plans to enroll 100 children.","Participants' dental anxiety will be measured immediately after treatment.",142,"Participants will use the Tactile Pre-Visit Imagery Booklet before their dental treatment. Anxiety will be measured before the intervention and immediately after treatment.","Not stated in the trial record.",[],"v2"]