- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07075458
- Original Trial
Effectiveness Of Magic Tricks Distraction Technique
Effectiveness Of Magic Tricks Distraction Technique In Reducing Anxiety In 3-7 Years-Old Children During Local Anesthesia Administration
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35516
- Faculty of Dentistry, Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children in the age group of 3 to 7 years old.
- Children without any past dental treatment experience under local anesthesia.
Exclusion Criteria:
- Children with a systemic diseases.
- Children with an extreme disruptive behavior.
- Children with acute dental pain or swelling.
- Children with problems in their intellectual functions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magic Rope Trick
Children will be distracted using a magic rope trick during local anesthesia administration.
|
Children will be distracted using a magic rope trick during local anesthesia administration.
|
|
Experimental: Magic Thumb Sleeves
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
|
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
|
|
Experimental: Tell-Show-Do (TSD)
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
|
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)
Time Frame: Baseline immediately before local anesthesia administration at the same visit-periprocedural
|
Dental anxiety will be assessed using the RMS-PS scale immediately before local anesthesia administration.
|
Baseline immediately before local anesthesia administration at the same visit-periprocedural
|
|
Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)
Time Frame: Immediately after local anesthesia administration at the same visit
|
Dental anxiety will be assessed using the RMS-PS scale immediately after local anesthesia administration.
|
Immediately after local anesthesia administration at the same visit
|
|
heart rate using pulse oximeter
Time Frame: periprocedural
|
periprocedural
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nadia farrag, phd, Mansoura University
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A0403024PP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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