Evaluating the effect of breathing exercise using a bubble blower on anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 10 years: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
AIM: To evaluate the effect of breathing exercise using BUBBLE BLOWER on anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 10 years.
OBJECTIVE:
- To assess intensity of pain using Wong-Baker FACES Pain rating scale (WBFPS) and Faces, Legs, Activity, Cry and Consolability scale (FLACC)
- To assess anxiety using Facial Imaging Scale (FIS).
The healthy children’s aged between 6-10 years, who reported in the Department of Pediatric and Preventive Dentistry of RUHS College Of Dental Sciences, Jaipur that met the defined inclusion criteria were recruited to participate in this clinical study.
About 40 children are randomized into two groups. The first group received the instruction of BE as well as a commercial bubble blower at first visit. Patients and their parents are asked to practice with the bubble blower 4–5 times daily for 7 days and record every practice in a chart prepared in advance by the investigator. The second group did not receive BE instruction nor were they given bubble blower at the first visit. After 7 days, during second visit L.A. will be introduced in both the groups.
Pre-treatment baseline anxiety will be recorded using the FIS for all the children and pulse rate will be measured at first visit. Procedural pain will be assessed using Faces, Legs, Activity, Cry and Consolability scale (FLACC) and WBFPS. Finally, anxiety will be again recorded after procedure & the data were evaluated using statistical analysis
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
- •Frankl’s behavior rating 3-4 Aged 6 to 10 year-old with moderate to severe anxiety (score 3 to 5 of FIS) Requiring pulp therapy or extraction of primary mandibular molars.
排除标准
- •Uncooperative behavior of patient Use of analgesic before treatment Previous history of dental treatment, systemic illnesses, physical or intellectual disabilities, or anesthetic allergy.
结局指标
主要结局
Intensity of pain
时间窗: At Baseline and 1 week after intervention
次要结局
- anxiety assessment(Baseline & 1 week after intervention)
研究者
DR NIRBHAY VASHISTHA
RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016