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Clinical Trial NCT07462364 (Pain) for Dental Anxiety, Dental Fear, Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Effect of a Kaleidoscope and Cartoons for Dental Treatment in Children (Pain) 126 Randomized Pediatric
Clinical Trial NCT07462364 (Pain) is an interventional study for Dental Anxiety, Dental Fear, Pain that is recruiting. It started on March 10, 2026 with plans to enroll 126 participants. Led by Dicle University, it is expected to complete by May 10, 2026. The latest data from ClinicalTrials.gov was last updated on March 13, 2026.
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 prefe...Show More
Detailed Description
Dental fear and anxiety are common in pediatric dentistry and can negatively affect children's cooperation and acceptance of treatment. Local anesthesia injections are a major source of pain and anxiety in children during dental procedures. While pharmacological methods may be effective in managing pain and anxiety, non-pharmacological behavioral techniques, particularly distraction methods, are increasingly used to ...Show More
Official Title
The Effect of a Kaleidoscope and Cartoons on Pain and Anxiety Associated With Local Anesthetic Injection for Dental Treatment in Children
Conditions
Dental AnxietyDental FearPainOther Study IDs
- Pain
- 21.11.2025/730
NCT ID Number
Start Date (Actual)
2026-03-10
Last Update Posted
2026-03-13
Completion Date (Estimated)
2026-05-10
Enrollment (Estimated)
126
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Dental anxiety, dental fear, pain, local anesthesia, children
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalKaleidoscope Group 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 | Kaleidoscope Distraction 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. |
ExperimentalCartoon Distraction Group 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. | Cartoon Distraction 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. |
No InterventionControl Group Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Fear level during local anesthesia injection measured using the Children's Fear Scale | Children's fear level during the dental injection procedure will be assessed using the Children's Fear Scale. The scale includes five facial expressions ranging from 0 (no fear) to 4 (extreme fear). The child will indicate the face that best represents their level of fear. | Immediately before and immediately after the local anesthesia injection |
Anxiety level measured using the Children's Anxiety Scale-State (CAS-S) | Children's situational anxiety level will be assessed using the Children's Anxiety Scale-State. The scale is designed as a thermometer-like visual scale ranging from 0 to 10, where higher scores indicate higher anxiety levels. | Immediately before and immediately after the local anesthesia injection |
Child behavior during dental treatment measured using the Frankl Behavior Rating Scale | Children's behavior during the dental procedure will be evaluated using the Frankl Behavior Rating Scale, which categorizes behavior into four levels: definitely negative, negative, positive, and definitely positive. | During the local anesthesia administration procedure |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
7 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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
Dicle UniversityStudy Responsible Party
Elif Bilsin Kocamaz, Principal Investigator, Associate Professor, Dicle University
Study Central Contact
Contact: Elif Bilsin Kocamaz, PhD, +904122411000, [email protected]
Contact: Sumeyye Tokmak, BsN, +904122411000, [email protected]
1 Study Locations in 1 Countries
Diyarbakır
Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University, Diyarbakır, Diyarbakır, 21000, Turkey (Türkiye)
Elif Bilsin Kocamaz, Associate Professor, Contact, +90 412 241 10 00, [email protected]
Recruiting