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NCT Number: NCT07462364

The Effect of a Kaleidoscope and Cartoons 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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University

Diyarbakır, 21000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elif Bilsin Kocamaz, Associate Professor

CONTACT

[email protected]

+90 412 241 10 00 ext. 2693

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kaleidoscope Distraction

Behavioral

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 Distraction

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif Bilsin Kocamaz, PhD

CONTACT

[email protected]

+904122411000 ext. 2693

Sumeyye Tokmak, BsN

CONTACT

[email protected]

+904122411000 ext. 2693

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

The Effect of a Kaleidoscope and Cartoons on Pain and Anxiety Associated With Local Anesthetic Injection for Dental Treatment in Children

Acronym: Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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