An interventional study of Kaleidoscope Distraction and Cartoon Distraction in Dental Anxiety, Dental Fear and Pain, sponsored by Dicle University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Dicle University · Not applicable, Interventional, and Prevention
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.
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 reduce discomfort.
This randomized controlled trial aims to evaluate the effects of two distraction techniques-kaleidoscope use and cartoon viewing-on pain, fear, and anxiety associated with local anesthetic 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 7-12 years who require local infiltration anesthesia will be included. Participants will be randomly assigned to one of three groups: Kaleidoscope Group, Cartoon Distraction Group, or Control Group. Children in the Kaleidoscope Group will use a kaleidoscope during the injection, while children in the Cartoon Group will watch cartoons. In the Control Group, injections will be administered according to routine clinical procedures without distraction.
Pain, fear, and anxiety 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 be evaluated with the Frankl Behavior Rating Scale. Data collection will occur during the dental procedure and immediately after the injection.
This study is expected to provide evidence on the effectiveness of simple, non-pharmacological distraction techniques in reducing pain and anxiety in pediatric patients undergoing local anesthesia injections.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 126 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique.
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.
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.
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.
Time frame: Immediately after the local anesthesia injection
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.
Time frame: 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.
Time frame: 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.
Time frame: During the local anesthesia administration procedure
Plan to share: No
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Started Mar 2026 (actual). Primary completion is estimated for May 2026, 1 month after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 1 month is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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