NCT07462364

Brief Summary

Dental fear and anxiety are among the most common challenges encountered in pediatric dental practice and may negatively affect children's cooperation and acceptance of dental treatment. Local anesthesia injections are considered one of the main sources of pain and anxiety during dental procedures in children. Although pharmacological methods can be effective in managing pain and anxiety, they may not always be preferred due to potential side effects, limited applicability, and the possibility of increasing stress in children. Therefore, non-pharmacological behavioral management techniques, particularly distraction methods, are increasingly used in pediatric dentistry to reduce pain perception and anxiety. The aim of this randomized controlled trial is to evaluate the effects of kaleidoscope use and cartoon distraction on pain, fear, and anxiety associated with local anesthesia injections in children undergoing dental treatment. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. A total of 126 children aged between 7 and 12 years who require local infiltration anesthesia during dental treatment will be included in the study. Participants will be randomly assigned to one of three groups: the Kaleidoscope Group, the Cartoon Distraction Group, or the Control Group. Children in the kaleidoscope group will use a kaleidoscope during the local anesthesia injection, while children in the cartoon group will watch cartoons during the procedure. In the control group, local anesthesia will be administered according to the routine clinical procedure without any distraction technique. Pain, fear, and anxiety levels will be assessed using the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale, and the Children's Anxiety Scale-State. Behavioral responses will also be evaluated using the Frankl Behavior Rating Scale. The findings of this study are expected to provide evidence regarding the effectiveness of simple and non-pharmacological distraction techniques in reducing pain and anxiety associated with local anesthesia injections in pediatric dental patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 5, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Dental anxiety, dental fear, pain, local anesthesia, children

Outcome Measures

Primary Outcomes (1)

  • Pain level during local anesthesia injection measured using the Wong-Baker FACES Pain Rating Scale

    Pain perception during the administration of local anesthesia will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children will be asked to select the face that best represents the pain they experienced during the injection.

    Immediately after the local anesthesia injection

Secondary Outcomes (3)

  • Fear level during local anesthesia injection measured using the Children's Fear Scale

    Immediately before and immediately after the local anesthesia injection

  • Anxiety level measured using the Children's Anxiety Scale-State (CAS-S)

    Immediately before and immediately after the local anesthesia injection

  • Child behavior during dental treatment measured using the Frankl Behavior Rating Scale

    During the local anesthesia administration procedure

Study Arms (3)

Kaleidoscope Group

EXPERIMENTAL

Children in this group will use a kaleidoscope during the administration of local infiltration anesthesia as a visual distraction technique. The child will be instructed on how to use the kaleidoscope before the injection and will continue using it throughout the procedure

Behavioral: Kaleidoscope Distraction

Cartoon Distraction Group

EXPERIMENTAL

Children in this group will watch cartoons as an audiovisual distraction technique during the administration of local infiltration anesthesia. The cartoon will be started before the injection and will continue throughout the procedure.

Behavioral: Cartoon Distraction

Control Group

NO INTERVENTION

Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique.

Interventions

Children will use a kaleidoscope as a visual distraction technique during the administration of local infiltration anesthesia. Before the procedure, the researcher will explain how to use the kaleidoscope, and the child will continue using it throughout the injection.

Kaleidoscope Group

Children will watch cartoons as an audiovisual distraction technique during the administration of local infiltration anesthesia. The cartoon will be started immediately before the injection and will continue throughout the procedure.

Cartoon Distraction Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 7 and 12 years
  • Children requiring local infiltration anesthesia for dental treatment
  • Children who apply to the Pediatric Dentistry Clinic of Dicle University Faculty of Dentistry
  • Children and their parents who voluntarily agree to participate in the study and provide informed consent
  • Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale

You may not qualify if:

  • Children with chronic diseases
  • Children with a history of hospitalization or surgery
  • Children with neurological or behavioral disorders such as autism, attention deficit hyperactivity disorder (ADHD), or learning disabilities
  • Children with mental retardation, hearing impairment, or speech problems
  • Children with dental abscesses or fistulas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University

Diyarbakır, Diyarbakır, 21000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Bilsin Kocamaz, Associate Professor

    Dicle University

    STUDY DIRECTOR
  • Elif Bilsin kocamaz, PhD

    Dicle University

    STUDY DIRECTOR

Central Study Contacts

Elif Bilsin Kocamaz, PhD

CONTACT

Sumeyye Tokmak, BsN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups: the Kaleidoscope Group, the Cartoon Distraction Group, or the Control Group. Children in the kaleidoscope group will use a kaleidoscope during the administration of local anesthesia, while children in the cartoon group will watch cartoons during the injection procedure. In the control group, local anesthesia will be administered according to the routine clinical procedure without any distraction technique. Pain, fear, and anxiety levels will be assessed before and after the procedure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

March 10, 2026

Primary Completion

May 1, 2026

Study Completion

May 10, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations