Effect of Play Dough, Slime, and Plush Toys on Dental Anxiety and Pain in Children During Dental Treatment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Play Dough Distraction
  Use of play dough as a tactile distraction during pediatric dental treatment to reduce anxiety and pain perception.
• Поведенческое Slime Distraction
  Use of slime as a tactile distraction during pediatric dental treatment.
• Поведенческое Plush Toy Distraction
  Use of a plush toy as a tactile distraction during pediatric dental treatment.
• Поведенческое No Distraction (Control)
  Standard restorative dental treatment without distraction material.

Первичные конечные точки

• Dental Anxiety Level Assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) [Срок оценки: Immediately before the dental procedure (baseline) and immediately after completion of the dental procedure (same day, periprocedural)]
• Physiological Stress Response - Cortisol [Срок оценки: During the dental procedure (at the 10th minute of treatment)]

Вторичные конечные точки (2)

• Pain Perception Assessed by the Wong-Baker FACES Pain Rating Scale [Срок оценки: Immediately after completion of the dental procedure (same day, periprocedural assessment)]
• Physiological Stress Response Assessed by Heart Rate Measurement Using Pulse Oximetry [Срок оценки: Baseline (immediately before the dental procedure), during the dental procedure (periprocedural monitoring), and immediately after completion of the dental procedure (same day assessment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07445594 · 25.DUS.005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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