Inönü university faculty of dentistry
Malatya, Battalgazi, 44050, Turkey (Türkiye)
NCT Number: NCT07209696
This study is designed to evaluate strategies for reducing dental anxiety in pediatric patients. The commonly applied "Tell-Show-Do" method involves explaining and demonstrating dental procedures before they are performed. In this randomized controlled trial, three groups of children will be compared:
Children who receive only the Tell-Show-Do method,
Children who are prepared at home with a storybook prior to receiving the Tell-Show-Do method,
Children who are prepared at home with an animation video prior to receiving the Tell-Show-Do method.
Children's dental anxiety will be assessed using validated behavioral observation scales, including baseline measurement at the first examination, after preparation, and following completion of dental treatment. The study will determine whether the addition of a storybook or an animation video provides greater effectiveness in reducing dental anxiety compared with the Tell-Show-Do method alone.
This study is active but is not currently recruiting participants.
Notify Me4 year–8 year
All sexes
Interventional
Not applicable
Malatya, Battalgazi, 44050, Turkey (Türkiye)
Dental anxiety is a frequent challenge in pediatric dentistry and can complicate patient cooperation, lead to incomplete treatment, or necessitate the use of general anesthesia. Among the available behavior guidance techniques, the Tell-Show-Do (TSD) method is the most widely applied and has been shown to facilitate children's acceptance of dental procedures. However, recent approaches suggest that additional child-friendly strategies, such as storybooks and animation videos, may further enhance its effectiveness in reducing anxiety and improving cooperation.
This randomized controlled trial aims to evaluate the impact of incorporating a storybook or an animation video in addition to the TSD method on children's dental anxiety and cooperative behavior. Participants will be randomly assigned to one of three groups:
Control group: Tell-Show-Do only.
Storybook group: Children will be prepared at home with a storybook prior to the dental visit, followed by Tell-Show-Do.
Animation video group: Children will be prepared at home with an animation video prior to the dental visit, followed by Tell-Show-Do.
Children's anxiety and cooperation will be assessed at three time points: baseline (first examination), after preparation (before treatment), and after completion of dental treatment. The primary outcome measure will be the Jeet Wheel behavioral observation scale, which provides standardized ratings of children's anxiety and cooperation during dental procedures. In addition, baseline dental fear will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), and the potential need for general anesthesia will be evaluated with the SCAN Index.
Data will be analyzed using mixed-effects models to examine the interaction between time (three assessment points) and group (three interventions), while controlling for CFSS-DS and SCAN Index scores. This design will enable comparisons of the relative effectiveness of each intervention independent of baseline differences.
The study is expected to provide new evidence on whether storybook and animation video adjuncts can enhance the effectiveness of the Tell-Show-Do method, offering more child-friendly approaches to reducing dental anxiety in pediatric dental practice.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The conventional behavior guidance technique in pediatric dentistry, where the dentist explains and demonstrates dental procedures before performing them.
Home-based preparation using a child-friendly storybook that introduces the dental visit, instruments, and procedures in simple language and illustrations.
The conventional behavior guidance method where the dentist explains and demonstrates dental procedures before performing them, to reduce anxiety and improve cooperation.
Time frame: Baseline (Day 1, first examination before intervention) Immediately after preparation, before dental treatment (Day 1, pre-treatment) Immediately after completion of dental treatment (Day 1, post-treatment)
The Jeet Wheel Scale (JWS) (Chakraborty et al., 2024) is a validated child-friendly tool for evaluating dental anxiety and cooperation. The scale ranges from 1 to 8, represented by expressive emoji faces from Excited (1) to Shouting (8). Lower scores indicate no or minimal anxiety with good cooperation, whereas higher scores indicate severe anxiety and poor cooperation. Children will be asked to select the emoji that best represents their feelings, and the score will be recorded at each time point.
Time frame: Day 1 (Immediately after preparation, before treatment)
The Jeet Wheel Scale will be assessed immediately after preparation (storybook/video vs. Tell-Show-Do only). Group differences will be analyzed using adjusted statistical models. Scores range from 1 to 8, with higher scores indicating greater anxiety.
Time frame: Day 1 (Immediately after completion of dental treatment, post-treatment).
The percentage of participants with a Jeet Wheel score of ≥ 4 will be compared between groups. A higher proportion indicates a greater number of children with clinically relevant anxiety.
Time frame: Throughout the dental visit(s) on Day 1.
Any adverse events or intolerance related to the behavioral preparation (storybook or video) will be recorded. Examples include refusal to proceed with treatment or discontinuation. Such events are expected to be rare.
Time frame: Day 1 (Baseline, before intervention).
The CFSS-DS is a parent-reported measure of children's dental fear. It includes 15 items, each rated 1-5, with total scores ranging from 15 to 75. Higher scores indicate greater dental fear. A score ≥38 indicates clinically significant fear. This score will be collected at baseline and used as a covariate in statistical analysis.
Time frame: Day 1 (Baseline, before intervention).
The SCAN Index (Scheduled Care Assessment for Need of General Anesthesia) is used to evaluate the potential need for dental treatment under general anesthesia. Higher scores indicate a greater likelihood of requiring GA. This score will be collected at baseline and included as a covariate in analysis.
Inonu University
Other
Randomized Controlled Evaluation of Storybook and Animation Video as Adjuncts to the Tell-Show-Do Technique in Pediatric Dentistry
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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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