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Investigating the effectiveness of distraction cards on reducing pain and anxiety during local anesthetic injection of maxillary infiltrate in children 3-6 years old:randomized clinical trial

Investigating the effectiveness of distraction cards on reducing pain and anxiety during local anesthetic injection of maxillary infiltrate in children 3-6 years old:randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250308064976N3
Enrollment
60
Registered
2025-08-04
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Investigating the effectiveness of distraction cards on reducing pain and anxiety during local anesthetic injection of maxillary infiltrate in children 3-6 years old:randomized clinical trial.

Interventions

Intervention 1: Intervention group: - Familiarization with the treatment environment and tools used such as the numbing gel and distraction cards - Local anesthesia injection using 20% benzocaine gel

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Participants must be healthy children aged 3 to 6 years, with no history of illness, surgery, or dental treatment. Requires deep restoration of a unilateral primary tooth. There must be parental consent to participate in the study. Children should behave positively during the examination.

Exclusion criteria

Exclusion criteria: history of illness or surgery physical or mental disorder Significant behavioral problems Non-cooperation during examination History of dental treatment Pain or inflammation at the injection site Parental non-consent to participate in the study

Design outcomes

Primary

MeasureTime frame
Heartbeat. Timepoint: Before intervention, during intervention, after intervention. Method of measurement: Pulse oximeter.;Wong-Baker. Timepoint: After intervention. Method of measurement: A 6-state questionnaire with a score of 10.;FLACCI. Timepoint: After inventation. Method of measurement: Grading table of FLACCI.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReyhaneh Faghihian

Esfahan University of Medical Sciences

r.faghihian@dnt.mui.ac.ir+98 913 205 3106

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026