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

NCT ID: NCT01398007

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-04-30

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.

Conditions

Anxiety; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional syringe

Conventional syringe

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Camouflage syringe

Intervention Type: PROCEDURE

Dental anesthesia is administered using the camouflaged syringe.

Interventions

Camouflage syringe

Dental anesthesia is administered using the camouflaged syringe.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lata Medical Research Foundation, Nagpur

OTHER

Sponsor Role: collaborator

Government Dental College and Hospital, India

OTHER_GOV

Sponsor Role: lead

Responsible Party

Shweta Ujaoney

Student Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinay K Hazarey, MDS

Role: STUDY_CHAIR

Government Dental College and Hospital, India

Jyoti Tote, MDS

Role: STUDY_DIRECTOR

Government Dental College and Hospital, India

Pushpa V Hazarey, MDS

Role: STUDY_DIRECTOR

Government Dental College and Hospital, India

Locations

Government Dental College and Hospital

Nagpur, Maharashtra, India

Countries

India

Other Identifiers

SUT2503

Identifier Type: -

Identifier Source: org_study_id