Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2024-04-01
2025-03-01
Brief Summary
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Detailed Description
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In 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.
This 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.
To ensure a comprehensive and objective assessment of anxiety, the study will employ a dual-modal evaluation approach:
Subjective 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.
Objective 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.
All 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.
The 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Magic Rope Trick group
Magic Thumb Sleeves group
Tell-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.
SUPPORTIVE_CARE
NONE
Study Groups
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Magic Rope Trick
Children will be distracted using a magic rope trick during local anesthesia administration.
Magic Rope Trick
Children will be distracted using a magic rope trick during local anesthesia administration.
Magic Thumb Sleeves
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
Magic Thumb Sleeves
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
Tell-Show-Do (TSD)
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
Tell-Show-Do (TSD)
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
Interventions
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Magic Rope Trick
Children will be distracted using a magic rope trick during local anesthesia administration.
Magic Thumb Sleeves
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
Tell-Show-Do (TSD)
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
Eligibility Criteria
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Inclusion Criteria
* Children without any past dental treatment experience under local anesthesia.
Exclusion Criteria
* Children with an extreme disruptive behavior.
* Children with acute dental pain or swelling.
* Children with problems in their intellectual functions.
3 Years
7 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Nadia farrag, phd
Role: STUDY_DIRECTOR
Mansoura University
Locations
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Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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References
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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.
Related Links
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Int J Clin Pediatr Dent . 2024 Dec 19;17(11):1296-1301. doi: 10.5005/jp-journals-10005-2998
Other Identifiers
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A0403024PP
Identifier Type: -
Identifier Source: org_study_id
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