Effectiveness of Three Pre-Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children: A Randomized crossover study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain perception during local anesthesia injection (measured by VAS, Wong-Baker Faces).
研究概览
简要总结
Title Effectiveness of Three Pre Anesthetic Surface Treatments in Reducing Pain and Anxiety During Local Anesthesia Injections in Children A Randomized Crossover Study
Objective To compare the effectiveness of cryotherapy low level laser therapy and vibrational stimulus in reducing pain and anxiety during intraoral local anesthesia injections in children aged 6 to 11 years
Design Randomized crossover study where each child receives all three interventions across different appointments
Interventions 1 Cryotherapy Ice application at the injection site 2 Low Level Laser Therapy Diode laser exposure before injection 3 Vibrational Stimulus Vibration applied before and during injection
Primary Outcomes Pain perception during injection Anxiety levels before and after injection
Secondary Outcomes Changes in physiological parameters pulse rate and SpO2 Patient satisfaction and preference
Tools Used Visual Analogue Scale Wong Baker Faces Scale Venham Picture Scale FLACC scale SEM scale Likert scale
Expected Benefit To identify the most effective non pharmacological method to improve comfort and reduce distress in pediatric dental patients undergoing local anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Requiring buccal infiltration anesthesia for dental treatment.
- •Requiring multiple dental appointments.
- •Classified as "negative" or "positive" on the Frankl Behavior Rating Scale (Annexure1).
- •Free of allergies to topical anesthetics used in the study.
- •Free from neurological or psychological disorders.
- •Parents provide informed consent, and children above 7 years provide assent.
排除标准
- •Children classified as "definitely negative" or "definitely positive" on the Frankl Behavior Rating Scale.
- •Patients where local anesthesia is contraindicated.
- •Children with special healthcare needs.
- •Patients unable to follow instructions due to psychological or developmental impairments.
- •Patients who decline to participate.
结局指标
主要结局
Pain perception during local anesthesia injection (measured by VAS, Wong-Baker Faces).
时间窗: at baseline, after 10 days then again after 10 days
Anxiety levels before and after injection (measured by Venham’s Picture Scale).
时间窗: at baseline, after 10 days then again after 10 days
次要结局
未报告次要终点
研究者
POONAM SHUKLA
KING GEORGE MEDICAL COLLEGE