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临床试验/NCT07515612
NCT07515612已完成不适用

The Effect of Valerian and Chamomile on Pediatric Dental Anxiety: A Randomized Controlled Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate and compare the effectiveness of chamomile extract and valerian extract in reducing dental anxiety in healthy pediatric patients aged 6 to 10 years undergoing tooth extraction. Participants will be randomly assigned to receive one of the herbal interventions or a placebo prior to extraction. Dental anxiety will be assessed using validated anxiety rating scales and physiological parameters. This study seeks to explore a safe, easy to apply, and effective approach to manage child behavior and reduce dental anxiety.

详细描述

Dental anxiety in children is a common issue that can negatively affect oral health, behavior, and overall well-being. While various pharmacological and non-pharmacological strategies exist to manage pediatric dental anxiety, there is still a need for approaches that are safe, accessible, and practical for routine clinical use. Herbal interventions, such as chamomile and valerian, have demonstrated anxiolytic and sedative effects in other medical settings, but their comparative effectiveness in reducing dental anxiety in children has not been fully studied.

This randomized controlled trial investigates the potential of these herbal extracts to reduce anxiety in children aged 6-10 years undergoing simple tooth extraction. Participants will be randomly assigned to one of three groups, receiving either chamomile, valerian, or a placebo prior to treatment. Anxiety will be assessed using multiple complementary methods: a child-friendly self-report scale, an observer-rated behavior scale, and physiological measures including blood pressure and heart rate.

By combining these assessment tools, the study provides a comprehensive evaluation of both psychological and physiological aspects of dental anxiety. The findings will offer insights into whether these herbal extracts can reduce dental anxiety safely and effectively, guiding pediatric dentists in implementing natural interventions to improve children's dental experiences.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children with no systemic or mental diseases.
  • Children aged 6-10 years.
  • Children with positive behavior according to the Frankl behavior rating scale.
  • Children requiring a simple tooth extraction of upper primary molars under local anesthesia.

排除标准

  • Children whose parents refused participation in the study.
  • Children who were unwilling to ingest any of the herbal extracts.
  • Children with a history of hypersensitivity to chamomile or valerian.
  • Children who had taken any sedative, anxiolytic or analgesic medications within the last 8 hours prior to treatment.

研究组 & 干预措施

Water

Placebo Comparator

干预措施: Water (Placebo) (Other)

Valerian extract

Experimental

干预措施: Valerian extract (Dietary Supplement)

Chamomile extract

Experimental

干预措施: Chamomile extract (Dietary Supplement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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