- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462364
The Effect of a Kaleidoscope and Cartoons for Dental Treatment in Children (Pain)
The Effect of a Kaleidoscope and Cartoons on Pain and Anxiety Associated With Local Anesthetic Injection for Dental Treatment in Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Bilsin Kocamaz, PhD
- Phone Number: 2693 +904122411000
- Email: elifbilsin-86@hotmail.com
Study Contact Backup
- Name: Sumeyye Tokmak, BsN
- Phone Number: 2693 +904122411000
- Email: tokmak.2113@gmail.com
Study Locations
-
-
Diyarbakır
-
Diyarbakır, Diyarbakır, Turkey (Türkiye), 21000
- Recruiting
- Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University
-
Contact:
- Elif Bilsin Kocamaz, Associate Professor
- Phone Number: 2693 +90 412 241 10 00
- Email: elifbilsin-86@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kaleidoscope 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
|
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.
|
|
Experimental: Cartoon 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.
|
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 Intervention: Control Group
Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level during local anesthesia injection measured using the Wong-Baker FACES Pain Rating Scale
Time Frame: Immediately after the local anesthesia injection
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fear level during local anesthesia injection measured using the Children's Fear Scale
Time Frame: Immediately before and immediately after the local anesthesia injection
|
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)
Time Frame: Immediately before and immediately after the local anesthesia injection
|
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
Time Frame: During the local anesthesia administration procedure
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elif Bilsin kocamaz, PhD, Dicle University
- Study Director: Elif Bilsin Kocamaz, Associate Professor, Dicle University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.11.2025/730
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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