Comparative evaluation of acceptability feasibility and satisfaction of buzzy bee and vibradent in relieving pain and anxiety during local anaesthesia administration during dental extraction A randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- 1)Compare vibradent and buzzy bee on reducing pain during LA administration in paediatric dental patients using WBFPS FLACC SEM scales at baseline(T0) at needle insertion(Tn) and three minutes after LA(Te)
研究概览
简要总结
The purpose of this randomized controlled trial is to compare the acceptability, feasibility, and satisfaction levels associated with the use of two pain and anxiety management devices—Buzzy® and Vibradent—during local anesthesia administration for dental extractions in children. Given the high prevalence of dental fear and anxiety among pediatric patients and the impact it has on treatment outcomes, this study aims to evaluate how these devices can improve the overall dental experience for both children and their caregivers. It is hypothesized that both Buzzy® and Vibradent will be effective in reducing pain and anxiety during local anesthesia administration, but Buzzy® may provide superior results due to its multimodal action (vibration + cryotherapy) compared to vibration-only intervention with Vibradent. Additionally, the study expects higher acceptability and satisfaction from both children and parents with the use of these devices, particularly Buzzy®
The primary outcome of the study are:
1)To quantify the effect of vibradent and buzzy bee on reducing pain during local anaesthesia administration in paediatric dental patients using self-report by patient using Wong baker faces pain scale (WBFPS) and observer reported pain assessment using Face Legs Activity Cry Consolability scale(FLACC) and Sound Eye Motor scale(SEM) scales at baseline(T0) at needle insertion(Tn) and three minutes after completion of local anaesthesia administration(Te)
2)To assess and compare anxiety levels at all lines of study using subjective (self-reported anxiety using FIS) and objective parameters using heart rate at T0 Tn and Te. Salivary cortisol levels are checked at T0 and T10 (Ten minutes after needle insertion).
3)To evaluate and compare the efficacy of vibrotactile and vibrotactile with cryotherapy in local infiltration and nerve blocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Cooperative patients with positive behaviour according to Frankel behaviour rating scale (FBRS).
- •Should be first visit of the patient to the dental clinic.
- •7 to 10-year-old children.
- •Patient who needs local anaesthesia, either maxillary infiltration or mandibular nerve block for extraction.
- •Free from any psychological and neurological disorder (Autism, Attention deficit hyperactivity disorder).
排除标准
- •Patients with congenital diseases.
- •Patients with respiratory diseases.
- •Medically compromised patients.
- •Children with significantly altered emotional state.
- •Children unable to quantify pain.
- •No history of drug allergy.
结局指标
主要结局
1)Compare vibradent and buzzy bee on reducing pain during LA administration in paediatric dental patients using WBFPS FLACC SEM scales at baseline(T0) at needle insertion(Tn) and three minutes after LA(Te)
时间窗: 10 minutes Before anaesthesia administration | During anaesthesia administration | 10 minutes after anaesthesia administration
2)Compare anxiety levels using FIS Heart rate and salivary cortisol
时间窗: 10 minutes Before anaesthesia administration | During anaesthesia administration | 10 minutes after anaesthesia administration
3) Compare their efficacy between local infiltration and nerve block
时间窗: 10 minutes Before anaesthesia administration | During anaesthesia administration | 10 minutes after anaesthesia administration
次要结局
- 1) To evaluate parent & patient acceptance & satisfaction using questionnaire.(2) To assess feasibility of the procedure by calculating time required to complete the procedure.)
研究者
Dr shajaratul yakeen nabi
Government dental college and hospital srinagar