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

This study has been completed.
Sponsor:
Collaborator:
Lata Medical Research Foundation
Information provided by:
Government Dental College and Hospital
ClinicalTrials.gov Identifier:
NCT01398007
First received: July 18, 2011
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Anxiety
Fear
 Procedure: Camouflage syringe
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Government Dental College and Hospital:

Primary Outcome Measures:
  • Venham's clinical rating scale [ Time Frame: Within 1 hour of procedure ] [ Designated as safety issue: No ]
    Venham's clinical rating scale for movement, crying and overall behavior


Secondary Outcome Measures:
  • Venham's Picture Test [ Time Frame: Within 1 hour of procedure ] [ Designated as safety issue: No ]
    Overall aceptability of the intervention

  • Parental Emotional Stress Questionnaire [ Time Frame: Within 1 hour of procedure ] [ Designated as safety issue: No ]
  • Recall questionnaire [ Time Frame: Within 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional syringe
Conventional syringe
 Procedure: Camouflage 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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398007

Locations
India
Government Dental College and Hospital
Nagpur, Maharashtra, India, 440003
Sponsors and Collaborators
Government Dental College and Hospital
Lata Medical Research Foundation
Investigators
Study Chair: Vinay K Hazarey, MDS Government Dental College and Hospital
Study Director: Jyoti Tote, MDS Government Dental College and Hospital
Study Director: Pushpa V Hazarey, MDS Government Dental College and Hospital
  More Information

No publications provided

Responsible Party: Shweta Ujaoney, Government Dental College and Hospital, Nagpur, India and Lata Medical Research Foundation, Nagpur, India
ClinicalTrials.gov Identifier: NCT01398007     History of Changes
Other Study ID Numbers: SUT2503
Study First Received: July 18, 2011
Last Updated: July 19, 2011
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013