NCT07462364 The Effect of a Kaleidoscope and Cartoons for Dental Treatment in Children
| NCT ID | NCT07462364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dicle University |
| Condition | Dental Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2026-03-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Elif Bilsin Kocamaz, Associate Professor
STUDY DIRECTOR
Dicle University
Frequently Asked Questions
Who can join the NCT07462364 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 12 Years, studying Dental Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07462364 currently recruiting?
Yes, NCT07462364 is actively recruiting participants. Contact the research team at elifbilsin-86@hotmail.com for enrollment information.
Where is the NCT07462364 trial being conducted?
This trial is being conducted at Diyarbakır, Turkey (Türkiye).
Who is sponsoring the NCT07462364 clinical trial?
NCT07462364 is sponsored by Dicle University. The principal investigator is Elif Bilsin Kocamaz, Associate Professor at Dicle University. The trial plans to enroll 126 participants.
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