Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT07075458
Brief Summary:
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
Detailed Description:
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.
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.
Study:
NCT07075458
Study Brief:
Protocol Section:
NCT07075458