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Completed

NCT Number: NCT01398007

Use of the Camouflage Syringe to Reduce 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.

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Key information

Conditions

Anxiety Anxiety Disorders Fear Mental Disorders

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Government Dental College and Hospital

Nagpur, Maharashtra, 440003, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camouflage syringe

Procedure

Dental anesthesia is administered using the camouflaged syringe.

Primary outcomes

  1. 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

  1. Venham's Picture Test

    Time frame: Within 1 hour of procedure

    Overall aceptability of the intervention

  2. Parental Emotional Stress Questionnaire

    Time frame: Within 1 hour of procedure

  3. Recall questionnaire

    Time frame: Within 2 weeks

Sponsors and collaborators

Lead sponsor

Government Dental College and Hospital, India

Other Gov

Collaborators

  • Lata Medical Research Foundation, Nagpur

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 20, 2011
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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