Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT07075458
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness Of Magic Tricks Distraction Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study; neither participants nor investigators are blinded to the intervention assignment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of three parallel groups:\n\nMagic Rope Trick group\n\nMagic Thumb Sleeves group\n\nTell-Show-Do (TSD) group Each group will receive a different distraction technique during local anesthesia administration. The interventions will be applied in parallel, and outcomes will be compared between groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)', 'timeFrame': 'Baseline immediately before local anesthesia administration at the same visit-periprocedural', 'description': 'Dental anxiety will be assessed using the RMS-PS scale immediately before local anesthesia administration.'}, {'measure': 'Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)', 'timeFrame': 'Immediately after local anesthesia administration at the same visit', 'description': 'Dental anxiety will be assessed using the RMS-PS scale immediately after local anesthesia administration.'}, {'measure': 'heart rate using pulse oximeter', 'timeFrame': 'periprocedural'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'referencesModule': {'references': [{'pmid': '33149401', 'type': 'BACKGROUND', 'citation': 'Konde S, Sumaiyya S, Agarwal M, Peethambar P. "Thaumaturgy"- A Novel Behavior-shaping Technique. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):318-321. doi: 10.5005/jp-journals-10005-1781.'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC11703761/', 'label': 'Int J Clin Pediatr Dent . 2024 Dec 19;17(11):1296-1301. doi: 10.5005/jp-journals-10005-2998'}]}, 'descriptionModule': {'briefSummary': 'Dental anxiety among children is a significant challenge in pediatric dentistry, often hindering effective dental care. This clinical study aims to evaluate the effectiveness of two magic tricks distraction techniques (magic rope and magic thumb sleeves) in reducing dental anxiety among children aged 3-7 years during local anesthesia administration, in comparison to the conventional Tell-Show-Do (TSD) technique. Anxiety will be measured using the Raghavendra, Madhuri, and Sujata Pictorial Scale (RMS-PS) and pulse oximeter for heart rate assessment', 'detailedDescription': "Dental anxiety in children poses a persistent challenge in pediatric dental practice, often leading to behavioral management difficulties, compromised treatment outcomes, and long-term avoidance of dental care. One of the most anxiety-inducing procedures for young patients is the administration of local anesthesia (LA), primarily due to fear of needles, unfamiliar instruments, and perceived pain. Traditional behavioral management techniques such as the Tell-Show-Do (TSD) method have been widely used to familiarize children with the dental setting and reduce procedural anxiety. However, the effectiveness of TSD during high-stress interventions like LA injections remains under debate, especially among younger children with limited cognitive development.\n\nIn response to the need for more engaging and effective behavior guidance strategies, distraction-based techniques-particularly those involving visual and interactive elements-have gained increasing interest. Among them, thaumaturgy, or the use of magic tricks, has emerged as a novel, non-pharmacological method for anxiety reduction in pediatric patients. Magic-based interventions are believed to captivate the child's attention, stimulate curiosity, and shift focus away from the source of fear, thereby promoting relaxation and behavioral cooperation.\n\nThis randomized controlled clinical trial is designed to evaluate the efficacy of two magic trick-based distraction techniques-the magic rope and magic thumb sleeves-in reducing dental anxiety in children aged 3 to 7 years, during the administration of local anesthesia. The intervention groups will be compared to a control group managed with the conventional TSD technique.\n\nTo ensure a comprehensive and objective assessment of anxiety, the study will employ a dual-modal evaluation approach:\n\nSubjective measurement using the Raghavendra, Madhuri, and Sujata Pictorial Scale (RMS-PS), which is specifically validated for young children and uses gender-specific real-life facial photographs to help participants express their emotional states accurately.\n\nObjective physiological measurement using pulse oximetry to monitor heart rate (HR) continuously, as HR is a well-established indicator of sympathetic nervous system activation during stress and anxiety.\n\nAll procedures will follow standardized protocols, with a dual-operator design: one clinician will administer the behavioral intervention (magic trick or TSD), while a separate clinician, blinded to the intervention group, will perform the LA injection. This design ensures methodological rigor by minimizing operator bias and isolating the effect of the behavioral technique on anxiety.\n\nThe outcomes of this study will contribute to the growing body of evidence on non-pharmacological anxiety management strategies in pediatric dentistry and may support the integration of magic-based distraction techniques as effective alternatives or adjuncts to conventional methods such as TSD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children in the age group of 3 to 7 years old.\n* Children without any past dental treatment experience under local anesthesia.\n\nExclusion Criteria:\n\n* Children with a systemic diseases.\n* Children with an extreme disruptive behavior.\n* Children with acute dental pain or swelling.\n* Children with problems in their intellectual functions.'}, 'identificationModule': {'nctId': 'NCT07075458', 'briefTitle': 'Effectiveness Of Magic Tricks Distraction Technique', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effectiveness Of Magic Tricks Distraction Technique In Reducing Anxiety In 3-7 Years-Old Children During Local Anesthesia Administration', 'orgStudyIdInfo': {'id': 'A0403024PP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magic Rope Trick', 'description': 'Children will be distracted using a magic rope trick during local anesthesia administration.', 'interventionNames': ['Behavioral: Magic Rope Trick']}, {'type': 'EXPERIMENTAL', 'label': 'Magic Thumb Sleeves', 'description': 'Children will be distracted using light-up magic thumb sleeves during local anesthesia administration', 'interventionNames': ['Behavioral: Magic Thumb Sleeves']}, {'type': 'EXPERIMENTAL', 'label': 'Tell-Show-Do (TSD)', 'description': 'Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration', 'interventionNames': ['Behavioral: Tell-Show-Do (TSD)']}], 'interventions': [{'name': 'Magic Rope Trick', 'type': 'BEHAVIORAL', 'description': 'Children will be distracted using a magic rope trick during local anesthesia administration.', 'armGroupLabels': ['Magic Rope Trick']}, {'name': 'Magic Thumb Sleeves', 'type': 'BEHAVIORAL', 'description': 'Children will be distracted using light-up magic thumb sleeves during local anesthesia administration', 'armGroupLabels': ['Magic Thumb Sleeves']}, {'name': 'Tell-Show-Do (TSD)', 'type': 'BEHAVIORAL', 'description': 'Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration', 'armGroupLabels': ['Tell-Show-Do (TSD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Nadia farrag, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data can be available forever after I complete publication', 'ipdSharing': 'YES', 'description': 'All the data can be shared', 'accessCriteria': 'internet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}