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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.
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. These baseline measures will be included as covariates in the statistical analysis to adjust for initial variability in anxiety and treatment requirements.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tell-Show-Do Only (Control) | Active Comparator | Children in this arm will receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment. No additional preparation such as storybook or animation video will be provided. |
|
| Storybook + Tell-Show-Do | Experimental | Children in this arm will be prepared at home with a child-friendly storybook that introduces the dental environment, instruments, and treatment steps in an age-appropriate manner. At the clinic, they will then receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment. |
|
| Animation Video + Tell-Show-Do | Experimental | Children in this arm will be prepared at home with an age-appropriate animation video introducing the dental environment, instruments, and treatment steps. At the clinic, they will then receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tell-Show-Do | Behavioral | The conventional behavior guidance technique in pediatric dentistry, where the dentist explains and demonstrates dental procedures before performing them. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dental anxiety and cooperation measured by the Jeet Wheel Scale | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group differences in Jeet Wheel scores after behavioral preparation | 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. | Day 1 (Immediately after preparation, before treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline dental fear assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inönü university faculty of dentistry | Malatya | Battalgazi | 44050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35327700 | Background | Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328. | |
| 35387187 | Background | Barrera-Avalos C, Luraschi R, Acuna-Castillo C, Vidal M, Mella-Torres A, Inostroza-Molina A, Vera R, Vargas S, Hernandez I, Perez C, Vallejos-Vidal E, Valdes D, Imarai M, Reyes-Lopez FE, Sandino AM. Description of Symptoms Caused by the Infection of the SARS-CoV-2 B.1.621 (Mu) Variant in Patients With Complete CoronaVac Vaccination Scheme: First Case Report From Santiago of Chile. Front Public Health. 2022 Mar 21;10:797569. doi: 10.3389/fpubh.2022.797569. eCollection 2022. |
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Individual participant data will not be shared due to privacy and confidentiality concerns in pediatric participants.
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| ID | Term |
|---|---|
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Participants will be randomly assigned to one of three parallel groups. The control group will receive the Tell-Show-Do (TSD) technique only. The second group will receive storybook preparation at home followed by TSD. The third group will receive animation video preparation at home followed by TSD. Each participant will remain in the assigned group for the duration of the study.
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The children, parents, and treating dentist were aware of the assigned intervention (storybook, animation video, or Tell-Show-Do only). However, the outcome assessor who rated children's anxiety using the Jeet Wheel scale was blinded to group allocation.
| Storybook Preparation | Behavioral | Home-based preparation using a child-friendly storybook that introduces the dental visit, instruments, and procedures in simple language and illustrations. |
|
| Animation Video Preparation | Behavioral | The conventional behavior guidance method where the dentist explains and demonstrates dental procedures before performing them, to reduce anxiety and improve cooperation. |
|
| Proportion of children with high anxiety at post-treatment (Jeet Wheel score ≥ 4) | 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. | Day 1 (Immediately after completion of dental treatment, post-treatment). |
| Safety and acceptability of behavioral preparations | 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. | Throughout the dental visit(s) on Day 1. |
| Day 1 (Baseline, before intervention). |
| Baseline need for general anesthesia assessed by the SCAN Index | 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. | Day 1 (Baseline, before intervention). |
| 26603167 | Background | Wang Q, Chen S, Li Y, Li P, Wu C, Wu Z, Wu Q, Sun F, Li J, Zheng W, Deng C, Zhang F, Li Y. Positive association of genetic variations in the phospholipase C-like 1 gene with dermatomyositis in Chinese Han. Immunol Res. 2016 Feb;64(1):204-12. doi: 10.1007/s12026-015-8738-x. |
| 12060873 | Background | Wiley DJ, Grosser S, Qi K, Visscher BR, Beutner K, Strathdee SA, Calhoun B, Palella F, Detels R; Multicenter AIDS Cohort Study Group. Validity of self-reporting of episodes of external genital warts. Clin Infect Dis. 2002 Jul 1;35(1):39-45. doi: 10.1086/340743. Epub 2002 Jun 6. |
| 17935573 | Result | Thyne SM, Marmor AK, Madden N, Herrick G. Comprehensive asthma management for underserved children. Paediatr Perinat Epidemiol. 2007 Nov;21 Suppl 3:29-34. doi: 10.1111/j.1365-3016.2007.00882.x. |