Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Venham's clinical rating scale
Study Overview
Brief Summary
Dental fear and anxiety in children constitue a crucial challenge to dental care delivery as well as future behavior related to dental problems in children. A common cause of such anxiety and fear is the procedural intervention that uses needles and syringes since a visual impact due to the needle acts as a deterrent to the child's cooperation during dental procedures. We therefore improvised the syringe such that it will camouflage the needle. We hypothesized that the use of this needle will alleviate the child's anxiety and therefore will demonstrate improved outcomes related to pain, fear and anxiety. This study is a group randomized trial to test the efficacy of the camouflage syringe as compared to the conventional syringe in children.
Detailed Description
The present study was conducted with an aim to evaluate the efficacy of a needle-covering camouflage syringe as compared to the conventional syringe in reducing dental anxiety and fear in children. The study was carried out in 100 children who consecutively reported to the study center and were allocated to the camouflage syringe arm or conventional syringe arm using block randomization to ensure equal distribution across trial arms. The study assessed the degree of dental anxiety and fear using Venham's clinical rating scale in conjunction with rating scale for movement, crying and overall behavior and Venham's Picture Test. The study also assessed parental emotional stress status when the child underwent the injection procedure and the reaction of the child after going home by Parental Emotional Stress Questionnaire and Recall Questionnaire, respectively. The study used appropriate statistical methods to determine the efficacy of the camouflage syringe in reducing the anxiety and fear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children reporting to study center with dental problems
- •Dental procedure requiring local anesthesia
- •Informed consent from the parents
Exclusion Criteria
- •Mentally challenged children
- •Medical problems negating use of local anesthesia and/or surgical intervention
Outcomes
Primary Outcomes
Venham's clinical rating scale
Time Frame: Within 1 hour of procedure
Venham's clinical rating scale for movement, crying and overall behavior
Secondary Outcomes
- Parental Emotional Stress Questionnaire(Within 1 hour of procedure)
- Venham's Picture Test(Within 1 hour of procedure)
- Recall questionnaire(Within 2 weeks)
Investigators
Shweta Ujaoney
Student Dentist
Government Dental College and Hospital, India