Dental AnxietyPainNCT07462364
The Effect of a Kaleidoscope and Cartoons for Dental Treatment in Children
A study testing Kaleidoscope Distraction and Cartoon Distraction in people with Dental Anxiety and Dental Fear, run by Dicle University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear, Pain
- What is being tested?
- Kaleidoscope Distraction and Cartoon Distraction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University
Diyarbakır, Diyarbakır, 21000
Elif Bilsin Kocamaz, Associate Professor, +90 412 241 10 00 ext. 2693, elifbilsin-86@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety, Dental Fear, Pain
- Being tested
- Kaleidoscope Distraction, Cartoon Distraction
- Keywords
- Dental anxiety, dental fear, pain, local anesthesia, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaleidoscope DistractionBehavioural
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.
Cartoon DistractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope Group | Experimental | 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 Receives: Behavioral: Kaleidoscope Distraction |
| Cartoon Distraction Group | Experimental | 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. Receives: Behavioral: Cartoon Distraction |
| Control Group | No intervention | Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the local anesthesia injection
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: During the local anesthesia administration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Mar 2026
- Primary completion1 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: the Kaleidoscope Group, the Cartoon Distraction Group, or the Control Group. Children in the kaleidoscope group will use a kaleidoscope during the administration of local anesthesia, while children in the cartoon group will watch cartoons during the injection 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 before and after the procedure.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Bilsin Kocamaz, Dicle University
- Investigators
- Elif Bilsin Kocamaz, Associate Professor, Study director, Dicle UniversityElif Bilsin kocamaz, PhD, Study director, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462364
- Sponsor's protocol ID
- 21.11.2025/730
- Acronym
- Pain
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Kaleidoscope and Cartoons on Pain and Anxiety Associated With Local Anesthetic Injection for Dental Treatment in Children
- ClinicalTrials.gov ID
- NCT07462364
- Acronym / sponsor ID
- Pain / 21.11.2025/730
- Conditions
- Dental Anxiety, Dental Fear, Pain
- Keywords
- Dental anxiety, dental fear, pain, local anesthesia, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: the Kaleidoscope Group, the Cartoon Distraction Group, or the Control Group. Children in the kaleidoscope group will use a kaleidoscope during the administration of local anesthesia, while children in the cartoon group will watch cartoons during the injection 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 before and after the procedure.
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope Group | Experimental | Behavioral: Kaleidoscope DistractionChildren 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 |
| Cartoon Distraction Group | Experimental | Behavioral: Cartoon DistractionChildren 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. |
| Control Group | No intervention | –Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaleidoscope DistractionChildren 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. | Behavioural | Kaleidoscope Group |
| Cartoon DistractionChildren 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. | Behavioural | Cartoon Distraction Group |
Primary outcome
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.
3 secondary outcomes
Fear level during local anesthesia injection measured using the Children's Fear Scale
Time frame: 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
Child behavior during dental treatment measured using the Frankl Behavior Rating Scale
Time frame: During the local anesthesia administration procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elif Bilsin Kocamaz, Associate Professor study director
Dicle University
Elif Bilsin kocamaz, PhD study director
Dicle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaleidoscope Distraction and Cartoon Distraction in people with Dental Anxiety and Dental Fear, run by Dicle University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Bilsin Kocamaz, PhD (+904122411000 ext. 2693, elifbilsin-86@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level during local anesthesia injection measured using the Wong-Baker FACES Pain Rating Scale (time frame: Immediately after the local anesthesia injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.