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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01398007
Enrollment
100
Registered
2011-07-20
Start date
2005-10-31
Completion date
2006-04-30
Last updated
2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Fear

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.

Interventions

Dental anesthesia is administered using the camouflaged syringe.

Sponsors

Lata Medical Research Foundation, Nagpur
CollaboratorOTHER
Government Dental College and Hospital, India
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Venham's clinical rating scaleWithin 1 hour of procedureVenham's clinical rating scale for movement, crying and overall behavior

Secondary

MeasureTime frameDescription
Venham's Picture TestWithin 1 hour of procedureOverall aceptability of the intervention
Parental Emotional Stress QuestionnaireWithin 1 hour of procedure
Recall questionnaireWithin 2 weeks

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026