A clinical trial on using a handmade dental memory card game to reduce the anxiety of children visiting to the dental office for the first time
Phase 2
- Conditions
- Health Condition 1: K050- Acute gingivitisHealth Condition 2: K025- Dental caries on pit and fissure surfaceHealth Condition 3: K026- Dental caries on smooth surface
- Registration Number
- CTRI/2023/11/060238
- Lead Sponsor
- Chettinad Dental College and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Children 5- 10 years of age visiting dentists requiring preventive and restorative treatments including, fluoride application, pit and fissure sealant application, oral prophylaxis, and restorations for the first time.
2.Children of Frankl behavior rating 3 ( NEGATIVE)
Exclusion Criteria
1. Children of Frankl behavior rating 1,2,4 (DEFINITELY POSITIVE, POSITIVE, DEFINITELY NEGATIVE)
2. Children complaining of pain and the presence of any abscess or fistula.
3. Children requiring local anesthesia for their treatment.
4. Children with any systemic complications, developmental disabilities, and cognitive disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome parameters: <br/ ><br>The dental anxiety of the children will be measured using the following scales <br/ ><br>1. RMS Pictorial Scale (RMS-PS) (scores 1-5 less anxious – very anxious) <br/ ><br>2. Frankl behavior rating score ( 1-4 definitely negative to definitely positive) <br/ ><br>Timepoint: On the same day at 6 points <br/ ><br>1.Before the treatment (on entering the hospital) <br/ ><br>2.After intervention(memory card game/communication) <br/ ><br>3.During the dental screening <br/ ><br>4.After the dental screening <br/ ><br>5.Before the dental treatment <br/ ><br>6.After the dental treatment (preventive and restorative procedures) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Heart rate(beats per minute) using pulse oximeter. <br/ ><br>Oxygen saturation (percentage) using pulse oximeter. <br/ ><br>Timepoint: On the same day at 6 points <br/ ><br>1.Before the treatment (on entering the hospital) <br/ ><br>2.After intervention(memory card game/communication) <br/ ><br>3.During the dental screening <br/ ><br>4.After the dental screening <br/ ><br>5.Before the dental treatment <br/ ><br>6.After the dental treatment (preventive & restorative procedures) <br/ ><br>