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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 9, 2025

Last Update Submit

July 18, 2025

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    Immediately after local anesthesia administration at the same visit

  • heart rate using pulse oximeter

    periprocedural

Study Arms (3)

Magic Rope Trick

EXPERIMENTAL

Children will be distracted using a magic rope trick during local anesthesia administration.

Behavioral: Magic Rope Trick

Magic Thumb Sleeves

EXPERIMENTAL

Children will be distracted using light-up magic thumb sleeves during local anesthesia administration

Behavioral: Magic Thumb Sleeves

Tell-Show-Do (TSD)

EXPERIMENTAL

Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration

Behavioral: Tell-Show-Do (TSD)

Interventions

Magic Rope TrickBEHAVIORAL

Children will be distracted using a magic rope trick during local anesthesia administration.

Magic Rope Trick
Magic Thumb SleevesBEHAVIORAL

Children will be distracted using light-up magic thumb sleeves during local anesthesia administration

Magic Thumb Sleeves
Tell-Show-Do (TSD)BEHAVIORAL

Children will receive the conventional Tell-Show-Do behavior management technique during local anesthesia administration

Tell-Show-Do (TSD)

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in the age group of 3 to 7 years old.
  • Children without any past dental treatment experience under local anesthesia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33149401BACKGROUND

Related Links

Study Officials

  • Nadia farrag, phd

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study; neither participants nor investigators are blinded to the intervention assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 20, 2025

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

March 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

All the data can be shared

Shared Documents
STUDY PROTOCOL
Time Frame
Data can be available forever after I complete publication
Access Criteria
internet

Locations

EG(1)