Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398007
• Other study ID #: SUT2503
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2011
• Last updated: March 10, 2015
• Start date: October 2005
• Est. completion date: April 2006

Study information

• Verified date: July 2011
• Source: Government Dental College and Hospital, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fear

Intervention

Procedure:
• Camouflage syringe
Dental anesthesia is administered using the camouflaged syringe.

Locations

Country	Name	City	State
India	Government Dental College and Hospital	Nagpur	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Government Dental College and Hospital, India	Lata Medical Research Foundation, Nagpur

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venham's clinical rating scale	Venham's clinical rating scale for movement, crying and overall behavior	Within 1 hour of procedure	No
Secondary	Venham's Picture Test	Overall aceptability of the intervention	Within 1 hour of procedure	No
Secondary	Parental Emotional Stress Questionnaire		Within 1 hour of procedure	No
Secondary	Recall questionnaire		Within 2 weeks	No