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临床试验/CTRI/2024/07/070525
CTRI/2024/07/070525尚未招募4 期

A Comparative Study Of The Card™ System And Tell-Show-Do Technique In The Behaviour Management Of 6–10-Year-Old Children.

Aadarsha Keerthi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
to check the effectiveness of card system in reducing the dental fear and anxiety in 6-10 years children

研究概览

简要总结

Dental fear and anxiety are prevalent psychological issues that significantly impact the provision of dental care, particularly in paediatric patients . These reactions can interfere with daily activities and present considerable challenges in delivering adequate dental treatments . Several factors contribute to the development of dental fear and anxiety in children, including previous negative experiences, parental anxiety, and the child’s temperament. Fear of the unknown, the sight and sound of dental instruments, and the potential for pain are common triggers. Dental fear can lead to avoidance of dental care, which exacerbates oral health problems and creates a cycle of increasing anxiety and deteriorating oral health . Therefore, addressing dental fear and anxiety in children is essential for their overall well-being and successful dental treatment outcomes .

 Various methods have been developed to manage children’s behaviour during dental visits, with nonpharmacological techniques gaining popularity due to their safety and effectiveness . These methods include parental presence and reassurance, distraction, relaxation techniques, systematic desensitisation, modelling, and the use of music or light physical contact. Previous studies have shown that these nonpharmacological techniques can effectively reduce anxiety and improve cooperation in paediatric patients, offering a safer and more holistic approach to managing child dental anxiety compared to pharmacological interventions . Among the various nonpharmacological techniques, the tell-show-do (TSD) technique is one of the most widely used in paediatric dentistry . TSD involves explaining the dental procedures to the child (tell), demonstrating the procedures using models or instruments (show), and then performing the procedure (do). This step-by-step approach aims to familiarise children with dental procedures, reduce their fear through clear communication, and build trust between the dentist and the child. The effectiveness of the TSD technique has been well-documented in previous studies, which have shown that it can significantly reduce anxiety and improve cooperative behaviour in children. Its simplicity and efficacy have made it a popular choice among paediatric dentists for managing child dental anxiety.

 The CARDâ„¢ system represents a newer approach that empowers children by involving them in the management of their dental anxiety. This system educates children on various evidence-based coping strategies, categorised into four letters: Comfort, Ask, Relax, and Distract . During dental treatment, children are invited to choose their preferred coping interventions from these categories, fostering a sense of control and participation in their care. Limited literature is available on the CARDâ„¢ system compared to the extensive research on the TSD technique. However, preliminary studies suggest that involving children in selecting coping strategies can enhance their sense of agency and reduce anxiety . The need for this study arises from the lack of comprehensive research comparing the effectiveness of the CARDâ„¢ system to the well-established TSD technique. This study aims to fill this gap by systematically evaluating the anxiety levels, physiological parameters, and behavioural responses of children managed with these two techniques, with the primary objective being to compare the effectiveness of the CARDâ„¢ system to the tell-show-do technique in managing the behaviour of 6–10-year-old children during dental procedures. Specifically, the study aims to determine which method is more effective in reducing anxiety and enhancing cooperation among paediatric patients. The null hypothesis is that there is no significant difference in the effectiveness of the CARDâ„¢ system and the tell-show-do technique in managing child dental anxiety. By systematically assessing anxiety levels and physiological and behavioural parameters before and after the procedures, this study will provide a comprehensive comparison of the two techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • childrens first visit physically and mentally healthy children demonstrating positive behaviour according to Wright’s modification of Frankl’s Behavior Rating Scale, necessitating an inferior alveolar nerve block for dental procedures such as extractions, pulpotomies,.

排除标准

  • children with prior dental treatment experience, history of unpleasant dental visits, acute painful oral conditions, known systemic diseases, recent prolonged hospitalisation, or physical disabilities.
  • Participants who did not provide informed consent were also excluded from the study.

结局指标

主要结局

to check the effectiveness of card system in reducing the dental fear and anxiety in 6-10 years children

时间窗: to check the effectiveness of card system in reducing the dental fear and anxiety in 6-10 years children

次要结局

  • Fear & Anxiety determination in the mean value of Spo2 & pulse rate.(Value recorded 10mins before the treatment in the waiting area & 10mins after the dental treatment.)

研究者

发起方
Aadarsha Keerthi
申办方类型
Other [self payment ]
责任方
Principal Investigator
主要研究者

Asvitha B

Chettiand Dental College and Research Institute

研究点 (1)

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