Evaluation of the Effectiveness of Play Dough, Slime, and Plush Toys on Dental Anxiety, Pain Perception, and Salivary Cortisol Levels in Children During Dental Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)
研究概览
简要总结
This study aims to evaluate the effectiveness of tactile distraction materials, including play dough, slime, and plush toys, on dental anxiety, pain perception, and physiological stress responses in children undergoing dental treatment. Ninety children aged 6-10 years receiving restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy, or control group without distraction. Dental anxiety and pain levels were assessed using validated psychometric scales, while physiological stress responses were evaluated through heart rate monitoring and salivary cortisol measurements. The study seeks to determine whether simple non-pharmacological distraction techniques can improve behavioral cooperation and reduce anxiety and pain perception during pediatric dental procedures. Findings may contribute to the development of child-friendly dental management strategies and enhance the quality of pediatric dental care.
详细描述
Dental anxiety in children remains a significant challenge in pediatric dentistry, often leading to behavioral management difficulties, delayed treatment, and negative long-term attitudes toward dental care. Non-pharmacological behavioral management strategies, including distraction techniques, are widely recommended to reduce anxiety and improve cooperation during dental procedures. Tactile distraction methods such as play dough, slime, and plush toys may provide sensory engagement that helps shift the child's attention away from dental stimuli; however, comparative evidence regarding their effectiveness remains limited.
This randomized controlled clinical study was designed to evaluate the relative effectiveness of different tactile distraction materials during routine pediatric dental treatment. Children aged 6-10 years requiring restorative dental treatment under local anesthesia were randomly assigned to one of four groups: play dough, slime, plush toy distraction, or a control group without distraction. Standardized clinical procedures were applied to all participants under similar clinical conditions.
Psychological responses were assessed using validated dental anxiety and pain perception scales, while physiological stress responses were monitored using heart rate measurements and salivary cortisol analysis. The study aims to provide evidence on whether simple, low-cost tactile distraction tools can enhance patient comfort, reduce perceived anxiety and pain, and support non-pharmacological behavior management approaches in pediatric dental practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-10 years requiring restorative dental treatment.
- •Indication for dental treatment under local anesthesia.
- •Ability to understand and respond to dental anxiety and pain assessment scales (CFSS-DS and Wong-Baker Faces Scale).
- •Children classified as ASA I or ASA II.
- •No prior exposure to the distraction materials used in the study during dental treatment.
- •Written informed consent obtained from parents or legal guardians.
排除标准
- •Presence of systemic diseases or medical conditions affecting stress response or contraindicating routine dental treatment
- •History of psychiatric, neurological, or developmental disorders that may impair cooperation or communication
- •Use of medications influencing anxiety, pain perception, heart rate, or cortisol levels
- •Requirement for sedation or general anesthesia for dental treatment
- •Acute dental infection or emergency treatment requiring immediate intervention
- •Refusal of participation by the child or parent/legal guardian
研究组 & 干预措施
Slime Distraction Group
Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management.
干预措施: Slime Distraction (Behavioral)
Play Dough Distraction Group
Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception.
干预措施: Play Dough Distraction (Behavioral)
Play Dough Distraction Group
Participants used play dough as a tactile distraction during restorative dental treatment under local anesthesia to reduce dental anxiety and pain perception.
干预措施: No Distraction (Control) (Behavioral)
Slime Distraction Group
Participants used slime as a tactile distraction during restorative dental treatment under local anesthesia to support anxiety and pain management.
干预措施: No Distraction (Control) (Behavioral)
Plush Toy Distraction Group
Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia.
干预措施: Plush Toy Distraction (Behavioral)
Plush Toy Distraction Group
Participants held a plush toy as a tactile distraction during restorative dental treatment under local anesthesia.
干预措施: No Distraction (Control) (Behavioral)
Control Group (No Distraction)
Participants received restorative dental treatment under local anesthesia without any distraction material.
干预措施: No Distraction (Control) (Behavioral)
结局指标
主要结局
Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)
时间窗: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)
Dental anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS is a validated 15-item psychometric questionnaire designed to measure dental fear and anxiety in children. Each item is scored on a 5-point Likert scale (1 = not afraid at all to 5 = very afraid), resulting in a total score ranging from 15 to 75. Higher scores indicate greater dental anxiety (worse outcome). The scale will be administered immediately before the dental treatment session and immediately after completion of the procedure to evaluate the effect of tactile distraction materials on anxiety levels during restorative dental treatment.
Physiological Stress Response - Cortisol
时间窗: During the dental procedure (at the 10th minute of treatment)
Physiological stress response will be assessed by measuring salivary cortisol levels as a biomarker of stress. Saliva samples will be collected before and after the dental treatment session using standardized collection procedures, and cortisol levels will be analyzed using an enzyme-linked immunosorbent assay (ELISA) method to evaluate the potential effects of tactile distraction materials on stress responses in pediatric dental patients.
次要结局
- Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale(Immediately after completion of the dental procedure (same day, periprocedural assessment))
- Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry(Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment))
研究者
Özgür Doğan
Assoc Prof.
Afyonkarahisar Health Sciences University