Effect of Computer-controlled vs. Conventional Injection on Pain and Anxiety in Children
- Conditions
- Dental Pain, Dental Anxiety and Child Behavior Are Assess in Response to Dental Injection
- Registration Number
- NCT07193342
- Lead Sponsor
- Future University in Egypt
- Brief Summary
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study evaluates differences in pain perception, Anxiety levels ,and behavioral responses during dental procedures among children. by using validated pain and behavior assessment scales, this trial seeks to determine whether the use of automated injection system can improve the overall dental experience for children
- Detailed Description
This randomized controlled trial aims to compare the effectiveness of Computer-Controlled automatic injection device versus conventional injection techniques in pediatric dental patients. The study focuses on evaluating and analyzing primary outcome ( pain perception) and secondary outcome ( anxiety levels )
Eligible participants will be healthy children who require dental treatment under local anesthesia. Participants will be randomly assigned to one of two Groups :
Groups A: Will receive The Star pen® system , incorporating battery-powered feedback for controlled pressure.
Group B: will receive conventional anesthetic syringe . pain will be assessed both subjectively using age- appropriate pain rating scales (such as Simplified Faces Pain Scale (S-FPS), and objectively using Sound, Eye, Motor scale .
Anxiety will be evaluated by measuring heart rate (objectively ). Child behavior during the procedure will be monitored and rated using venham's behavior scale.
This study aims to determine whether Star pen® system offers a more comfortable and less anxiety - provoking experience for children compared to the conventional method. The result may guide pediatric dentists in selecting the most suitable delivery technique to improve the dental experience and cooperation in pediatric patients.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sound, eye, motor scale Starting From point entry of anesthesia till end of injection procedure Simplified Faces Pain Scale Immediately after injection procedure
- Secondary Outcome Measures
Name Time Method Venham Behavior Rating Scale Starting From point of entry of anesthesia till end of injection procedure pulse oximeter From sitting of patient on dental chair till the end of the injection procedure