Comparison of reduction in anxiety using conscious sedation and conventional behaviour management techniques

Completed

• Conditions: Diseases of oral cavity and salivary glands,

• Registration Number: CTRI/2020/12/029699
• Lead Sponsor: Dr Rupali Barate

Brief Summary

In our study we plan to assess and compare

1) the overall average anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques.

2) the anxiety level in 6 to 12 year old children who receive dental treatment under two different protocols of nitrous oxide-oxygen sedation and conventional behavior management techniques on three different visits.

3) To compare anxiety level of children in the first treatment visit to anxiety level in the subsequent visit in all the groups.

Our proposed primary research hypothesis is nitrous oxide-oxygen sedation can reduce anxiety levels in 6 - 12 year old children compared to the conventional behavior management techniques in treatment and subsequent visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study Completion: 2021-09-09
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• ASA category 1 children aged 6-12 years.
• Children with CFSS –DS score above 32, indicative of moderate to high dental anxiety.
• Children requiring at least one procedure which requires LA administration and one restoration.

Exclusion Criteria

• Children suffering from any conditions which may hinder their participation.
• Children with limited cognitive abilities (cognitive impairment/intellectual disability) 3.
• Children whose parents refuse to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Venham’s clinical anxiety scale: A pre-validated 6 point scale.	Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
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.	Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Observer rating of behavior will be measured using	Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Facial image scale: A pre-validated 5 point scale.	Anxiety assessment will be done at the first visit that is baseline and after one week and after two weeks
Global rating scale: A pre-validated 5 point scale.	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 scale	Acceptability assessment will be done at the end of the visit that is baseline and one week after and two week after baseline

Trial Locations

Locations (1)

Y.M.T. dental college and hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

Y.M.T. dental college and hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Rupali Barate

Principal investigator

09702335638

rupali.barate79@gmail.com