Clinical trial NCT01398007: Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children
Official title: Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Fear
Lead sponsor: Government Dental College and Hospital, India
Sponsor class: OTHER_GOV
Collaborators: name: Lata Medical Research Foundation, Nagpur
First posted: 2011-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Venham's clinical rating scale
timeFrame: Within 1 hour of procedure
Secondary outcomes:
measure: Venham's Picture Test
timeFrame: Within 1 hour of procedure
measure: Parental Emotional Stress Questionnaire
timeFrame: Within 1 hour of procedure
measure: Recall questionnaire
timeFrame: Within 2 weeks
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Government Dental College and Hospital
state: Maharashtra
Study officials:
affiliation: Government Dental College and Hospital, India
name: Vinay K Hazarey, MDS
role: STUDY_CHAIR
affiliation: Government Dental College and Hospital, India
name: Jyoti Tote, MDS
role: STUDY_DIRECTOR
affiliation: Government Dental College and Hospital, India
name: Pushpa V Hazarey, MDS
role: STUDY_DIRECTOR
References: