Comparison of reduction in anxiety using conscious sedation and conventional behaviour management techniques
- Conditions
- Health Condition 1: K00-K14- Diseases of oral cavity and salivary glands
- Registration Number
- CTRI/2020/12/029699
- Lead Sponsor
- Dr Rupali Barate
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1. ASA category 1 children aged 6-12 years.
2. Children with CFSS ââ?¬â??DS score above 32, indicative of moderate to high dental anxiety.
3. Children requiring at least one procedure which requires LA administration and one restoration.
1. Children suffering from any conditions which may hinder their participation.
2. Children with limited cognitive abilities (cognitive impairment/intellectual disability)
3. Children whose parents refuse to give consent.
4. Children unable to breathe through their nose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Self-reported anxiety levels will be measured using Children�s fear survey schedule-Dental Subscale (CFSS-DS): 15 items rated on 5 point scale, ranging from 1 (not afraid) to 5 (very afraid). The total score is calculated by summing item score. <br/ ><br>Facial image scale: A pre-validated 5 point scale. <br/ ><br>Observer rating of behavior will be measured using <br/ ><br>Global rating scale: A pre-validated 5 point scale. <br/ ><br>Venham�s clinical anxiety scale: A pre-validated 6 point scale.Timepoint: Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
- Secondary Outcome Measures
Name Time Method Acceptability of nitrous oxide-oxygen sedation: will be assessed by likert scale: 3 point categorical scaleTimepoint: Acceptability assessment will be done at the end of the visit that is baseline and one week after and two week after baseline