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

Phase 2

Completed

• Conditions: Anxiety; Fear
• Interventions: Procedure: Camouflage syringe

• Registration Number: NCT01398007
• Lead Sponsor: Government Dental College and Hospital, India

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 Timeline

• Study Start: 2005-10
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Camouflage syringe	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.

Primary Outcome Measures

Name	Time	Method
Venham's clinical rating scale	Within 1 hour of procedure	Venham's clinical rating scale for movement, crying and overall behavior

Secondary Outcome Measures

Name	Time	Method
Parental Emotional Stress Questionnaire	Within 1 hour of procedure
Recall questionnaire	Within 2 weeks
Venham's Picture Test	Within 1 hour of procedure	Overall aceptability of the intervention

Trial Locations

Locations (1)

Government Dental College and Hospital; 🇮🇳 Nagpur, Maharashtra, India