Comparison of Anxiety & Stress levels in pre & post Inhalational sedation & Non-pharmacological technique in children – A Randomized Cross Over Clinical Trial.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Rashmi Chour
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To decrease anxiety and stress level
Overview
Brief Summary
• 40 children of age group 4-13 years, who reported to the department of pediatric and preventive dentistry were selected depending upon the inclusion criteria.
Children were assigned into two equal groups (n=20). The principal investigator performed the randomization process before beginning the study
Group A. (The conscious sedation group) 20 children were sedated by the rapid induction method by means of Nitrous oxide oxygen gas (inhalational)
Group B. 20 children will receive the treatment by conventional behavior management techniques. Pre and post anxiety levels were recorded with venham clinical anxiety scale and heart rate and spo2 levels by connecting the monitor.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
Eligibility Criteria
- Ages
- 4.00 Year(s) to 13.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children falling under ASA I & ASA II category Exhibiting moderate to severe anxiety.
- •Absence of mental retardation, no history drug therapy Presence of at least two primary molars requiring the treatment.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To decrease anxiety and stress level
Time Frame: 4 weeks
Secondary Outcomes
- Decreased anxiety & stress level in participants(8 weeks)
Investigators
Dr Rashmi Chour
Room number 9 Department of pedodontics PMNM dental college and hospital Bagalkot