CTRI/2024/06/068490尚未招募4 期
Evaluation of efficacy of nitrous oxide inhalation sedation on childs anxiety and parental perception during dental procedures :A Randomised clinical trial
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年7月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Modified Dental Anxiety Scale Score
研究概览
简要总结
| A Randomised clinical trial |
| design including 15 children with either of their parents (15)will be |
| selected from outpatient Department of |
| Paediatrics and Preventive Dentistry of Anil Neerukonda Institute of Dental |
| Sciences .Children under inclusion criteria ( moderate to severe anxiety) |
| during 1st dental visit requiring dental treatment will be |
| included .The whole procedure will be explained to parents and are allowed to |
| watch a videotape regarding dental treatment done under nitrous oxide |
| sedation. Written informed consent will be taken from parents, then complete |
| case history will be recorded and dental procedures will be done under |
| nitrous oxide inhalation sedation. Pre and Post operative anxiety level of |
| patient will be evaluated with modified dental anxiety scale (MDAS). To |
| understand the parent perception |
| levels parent will be allowed to complete the questionnaire using likert |
| scale. |
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
- 5.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Children under ASA I criteria Anxious /phobic patients Children with high fear susceptibility Children with high gag reflex Children with medical conditions aggravated by stress.
排除标准
- •Children below 4 years of age .
- •Children with ASA II and above.
- •Children with respiratory tract infections Children with Chronic Obstructive Pulmonary Disease.
- •Children with bowel obstruction or abdominal pain Children with middle ear infections/otitis media .
- •Children with vitamin B 12 deficiency Children undergoing treatment with bleomycin sulphate.
- •Children with psychiatric disorders..
- •Children underwent surgery involving anterior part of maxilla.
- •Children who do not satisfy any of the above inclusion criteria.
结局指标
主要结局
Modified Dental Anxiety Scale Score
时间窗: Baseline and Post Operative
次要结局
- Parental perception level regarding nitrous oxide treatment(Immediately after procedure)
研究者
Dr MATTA NAVYA
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES
研究点 (1)
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