CTRI/2026/03/105214尚未招募不适用
Effectiveness of Weighted Blanket–Induced Deep Pressure Stimulation on Dental Anxiety During Local Anaesthesia in Children: A Prospective Randomized Controlled Trial
Khushi Sethia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This study investigates whether weighted blankets, which provide calming deep pressure sensations, can reduce dental anxiety in children during local anaesthesia injections. Twenty children aged 6 to 10 years will be randomly assigned to receive anaesthesia with or without a weighted blanket. Anxiety will be measured using a child-friendly questionnaire (MCDAS) and heart-rate monitoring at five stages of the injection. The study aims to develop a safe, non-drug, child-friendly method to make dental visits more comfortable and reduce the fear of needles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- 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
- •Children aged 6 – 10 years ASA I–II health status Requiring local anaesthesia for dental treatment No previous intra-oral injection experience No known allergy to lidocaine No history of failed or painful dental procedures Cooperative behaviour (Frankl 3 or 4).
排除标准
- •History of painful or invasive medical/dental procedures Previous negative dental behaviour record Epilepsy or other neurological disorder Requirement for sedation or general anesthesia Medications influencing cortisol or autonomic function (e.g., corticosteroids).
研究者
Khushi Sethia
Saveetha dental college and hospital
研究点 (1)
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