Dental AnxietyNCT07075458
Effectiveness Of Magic Tricks Distraction Technique
A study testing Magic Rope Trick, Magic Thumb Sleeves and Tell-Show-Do (TSD) in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Magic Rope Trick, Magic Thumb Sleeves and Tell-Show-Do (TSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the age group of 3 to 7 years old.
- Children without any past dental treatment experience under local anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Effectiveness Of Magic Tricks Distraction Technique In Reducing Anxiety In 3-7 Years-Old Children During Local Anesthesia Administration
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
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Magic Rope Trick, Magic Thumb Sleeves, Tell-Show-Do (TSD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magic Rope TrickBehavioural
Children will be distracted using a magic rope trick during local anesthesia administration.
Magic Thumb SleevesBehavioural
Children will be distracted using light-up magic thumb sleeves during local anesthesia administration
Tell-Show-Do (TSD)Behavioural
Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration
| Study group | Role | What they receive |
|---|---|---|
| Magic Rope Trick | Experimental | Children will be distracted using a magic rope trick during local anesthesia administration. Receives: Behavioral: Magic Rope Trick |
| Magic Thumb Sleeves | Experimental | Children will be distracted using light-up magic thumb sleeves during local anesthesia administration Receives: Behavioral: Magic Thumb Sleeves |
| Tell-Show-Do (TSD) | Experimental | Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration Receives: Behavioral: Tell-Show-Do (TSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dental anxiety level as measured by RMS-PS (Raghavendra, Madhuri, and Sujata Pictorial Scale)
Dental anxiety will be assessed using the RMS-PS scale immediately before local anesthesia administration.
Measured: 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)
Dental anxiety will be assessed using the RMS-PS scale immediately after local anesthesia administration.
Measured: Immediately after local anesthesia administration at the same visit
heart rate using pulse oximeter
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: 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.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia farrag, phd, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075458
- Sponsor's protocol ID
- A0403024PP
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data can be shared
Publications
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.
PubMed 33149401
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Magic Tricks Distraction Technique In Reducing Anxiety In 3-7 Years-Old Children During Local Anesthesia Administration
- ClinicalTrials.gov ID
- NCT07075458
- Acronym / sponsor ID
- A0403024PP
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: 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.
| Arm | Type | Receives |
|---|---|---|
| Magic Rope Trick | Experimental | Behavioral: Magic Rope TrickChildren will be distracted using a magic rope trick during local anesthesia administration. |
| Magic Thumb Sleeves | Experimental | Behavioral: Magic Thumb SleevesChildren will be distracted using light-up magic thumb sleeves during local anesthesia administration |
| Tell-Show-Do (TSD) | Experimental | Behavioral: Tell-Show-Do (TSD)Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in the age group of 3 to 7 years old.
- Children without any past dental treatment experience under local anesthesia.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magic Rope TrickChildren will be distracted using a magic rope trick during local anesthesia administration. | Behavioural | Magic Rope Trick |
| Magic Thumb SleevesChildren will be distracted using light-up magic thumb sleeves during local anesthesia administration | Behavioural | Magic Thumb Sleeves |
| Tell-Show-Do (TSD)Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration | Behavioural | Tell-Show-Do (TSD) |
Primary outcome
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.
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.
heart rate using pulse oximeter
Time frame: periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 33149401Konde 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.
- Int J Clin Pediatr Dent . 2024 Dec 19;17(11):1296-1301. doi: 10.5005/jp-journals-10005-2998Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All the data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia farrag, phd study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magic Rope Trick, Magic Thumb Sleeves and Tell-Show-Do (TSD) in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07075458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.