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Clinical Trials/NCT01398007
NCT01398007
Completed
Phase 2

Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children

Government Dental College and Hospital, India1 site in 1 country100 target enrollmentOctober 2005
ConditionsAnxietyFear

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Anxiety
Sponsor
Government Dental College and Hospital, India
Enrollment
100
Locations
1
Primary Endpoint
Venham's clinical rating scale
Status
Completed
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
April 2006
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Government Dental College and Hospital, India
Responsible Party
Principal Investigator
Principal Investigator

Shweta Ujaoney

Student Dentist

Government Dental College and Hospital, India

Eligibility Criteria

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)

Study Sites (1)

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