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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Fear
• Intervention / Treatment: Procedure: Camouflage syringe

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Nagpur, Maharashtra, India, 440003
      • Government Dental College and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional syringe
Experimental: Camouflage syringe; The camouflage syringe is divided into three parts: head, body and tail. Head consists of bristles to apply topical anesthesia. The body holds the normally used conventional syringe and presents with a slot to check the aspiration results. The tail hides the conventional syringe loaded with the local anesthetic solution. This syringe is made up of cold-cure acrylic with a colorful toy-like look.	Procedure: Camouflage syringe; Dental anesthesia is administered using the camouflaged syringe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venham's clinical rating scale	Venham's clinical rating scale for movement, crying and overall behavior	Within 1 hour of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venham's Picture Test	Overall aceptability of the intervention	Within 1 hour of procedure
Parental Emotional Stress Questionnaire		Within 1 hour of procedure
Recall questionnaire		Within 2 weeks

Collaborators and Investigators

• Sponsor: Government Dental College and Hospital, India
• Collaborators: Lata Medical Research Foundation, Nagpur
• Investigators: Study Chair: Vinay K Hazarey, MDS, Government Dental College and Hospital, India; Study Director: Jyoti Tote, MDS, Government Dental College and Hospital, India; Study Director: Pushpa V Hazarey, MDS, Government Dental College and Hospital, India

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: SUT2503