The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MDAS
研究概览
简要总结
Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.
详细描述
This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.
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
- 否
入选标准
- •1.Aged 6-10 years; 2.Classified as American Society of Anesthesiologists (ASA) physical status I-II; 3.Required dental treatments such as caries filling, pulp therapy, or tooth extraction; 4.Informed consent obtained from the child's guardian.
排除标准
- •1.Contraindications to nitrous oxide inhalation, such as severe cardiopulmonary dysfunction, intestinal obstruction, or pneumothorax; 2.Mental illness or intellectual disability that would hinder cooperation with assessments or treatment; 3.Received dental sedation or general anesthesia within the past month;
研究组 & 干预措施
control group
The control group received only conventional local anesthesia and psychological comfort measures. Preoperatively, medical staff communicated thoroughly with the child and guardian to explain the treatment process and precautions, alleviating anxiety. The child's oral and systemic health was assessed to determine treatment difficulty. During treatment, articaine (Septodont, France) were administered under strict aseptic techniques to minimize pain. Continuous psychological support was provided through gentle communication, encouraging gestures, and distraction techniques such as soothing music or storytelling to help the child relax and cooperate. Postoperatively, the child was observed for any adverse reactions before being discharged with their guardian.
干预措施: psychological support (Behavioral)
experimental group
The experimental group received nitrous oxide anesthesia using a professional dental nitrous oxide inhalation sedation system (Matrx, the United States). This system featured precise gas concentration adjustment, real-time patient vital sign monitoring, and a reliable alarm system to ensure accurate, safe, and stable nitrous oxide administration.
干预措施: Nitrous Oxide Sedation (Drug)
结局指标
主要结局
MDAS
时间窗: From enrollment to the end of treatment at 1 week
The Modified Dental Anxiety Scale, zero is equivalent to no anxiety and 5 indicates the worst possible anxiety, participants achieved a response if they scored a performance status of 0 on a scale ranging from 0 (best outcome) to 5 (worst outcome)
Behavioral Observation Scale
时间窗: From enrollment to the end of treatment at 1 week
The Frankl behavior rating scale was used to assess the children's behavior during treatment. This 4-point scale categorizes behavior , participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 4 (worst outcome)
CFSS-DS
时间窗: From enrollment to the end of treatment at 1 week
Children's Fear Survey Schedule-Dental Subscale, participants achieved a response if they scored a performance status of 1 on a scale ranging from 1 (best outcome) to 5 (worst outcome)
次要结局
- HR(immediately after the intervention)
- BP(systolic and diastolic will be assessed immediately after the intervention)
- RR(immediately after the intervention)
研究者
Xu Renjie
Sub-Investigator
Shaoxing Maternity and Child Health Care Hospital