Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children
Primary Purpose
Anxiety, Fear
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Camouflage syringe
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
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
Sites / Locations
- Government Dental College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional syringe
Camouflage syringe
Arm Description
Conventional 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.
Outcomes
Primary Outcome Measures
Venham's clinical rating scale
Venham's clinical rating scale for movement, crying and overall behavior
Secondary Outcome Measures
Venham's Picture Test
Overall aceptability of the intervention
Parental Emotional Stress Questionnaire
Recall questionnaire
Full Information
NCT ID
NCT01398007
First Posted
July 18, 2011
Last Updated
March 10, 2015
Sponsor
Government Dental College and Hospital, India
Collaborators
Lata Medical Research Foundation, Nagpur
1. Study Identification
Unique Protocol Identification Number
NCT01398007
Brief Title
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
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Hospital, India
Collaborators
Lata Medical Research Foundation, Nagpur
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional syringe
Arm Type
No Intervention
Arm Description
Conventional syringe
Arm Title
Camouflage syringe
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Camouflage syringe
Intervention Description
Dental anesthesia is administered using the camouflaged syringe.
Primary Outcome Measure Information:
Title
Venham's clinical rating scale
Description
Venham's clinical rating scale for movement, crying and overall behavior
Time Frame
Within 1 hour of procedure
Secondary Outcome Measure Information:
Title
Venham's Picture Test
Description
Overall aceptability of the intervention
Time Frame
Within 1 hour of procedure
Title
Parental Emotional Stress Questionnaire
Time Frame
Within 1 hour of procedure
Title
Recall questionnaire
Time Frame
Within 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinay K Hazarey, MDS
Organizational Affiliation
Government Dental College and Hospital, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jyoti Tote, MDS
Organizational Affiliation
Government Dental College and Hospital, India
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pushpa V Hazarey, MDS
Organizational Affiliation
Government Dental College and Hospital, India
Official's Role
Study Director
Facility Information:
Facility Name
Government Dental College and Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
12. IPD Sharing Statement
Learn more about this trial
Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children
We'll reach out to this number within 24 hrs