The Effect of a Kaleidoscope and Cartoons for Dental Treatment in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorDicle University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Kaleidoscope Distraction
BehavioralChildren 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.
Cartoon Distraction
BehavioralChildren 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.
Treatment groups
126 Participants
are divided into 3 treatment groupsGroup A: Kaleidoscope GroupExperimental treatment 1 intervention
Group B: Cartoon Distraction GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Immediately after the local anesthesia injectionSecondary outcomes
1
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 injection2
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 injection3
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 procedureSponsors and contacts
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Source ClinicalTrials.gov