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

Comparison of anxiety level during treatment and subsequent visit between two different protocols of nitrous oxide-oxygen sedation and conventional behavior management in 6 to 12 year old children - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029699
Enrollment
45
Registered
2020-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K00-K14- Diseases of oral cavity and salivary glands

Interventions

Intervention1: Nitrous oxide-oxygen sedation vs conventional behavior management techniques: Nitrous oxide oxygen sedation is one of the effective methods of behavior management of anxious children. N

Sponsors

Dr Rupali Barate
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Facial image scale: A pre-validated 5 point scale. Observer rating of behavior will be measured using Global rating scale: A pre-validated 5 point scale. 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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Rupali Sheshrao Barate

Y.M.T dental college and hospital, kharghar

drsubhadrahn@gmail.com09702335638

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026