AnxietyPhase 2NCT01398007
Use of the Camouflage Syringe to Reduce Dental Anxiety and Fear in Children
A Phase 2 study testing Camouflage syringe in people with Anxiety and Fear, run by Government Dental College and Hospital, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 14 years
- What is being tested?
- Camouflage syringe
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children reporting to study center with dental problems
- Dental procedure requiring local anesthesia
- Informed consent from the parents
Who cannot join
- Mentally challenged children
- Medical problems negating use of local anesthesia and/or surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Camouflage Syringe in Reducing 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.
Read the 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.
- Being tested
- Camouflage syringe
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camouflage syringeProcedure or surgery
Dental anesthesia is administered using the camouflaged syringe.
| Study group | Role | What they receive |
|---|---|---|
| Conventional syringe | No intervention | Conventional syringe |
| Camouflage syringe | Experimental | 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. Receives: Procedure: Camouflage syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venham's clinical rating scale
Venham's clinical rating scale for movement, crying and overall behavior
Measured: Within 1 hour of procedure
Secondary outcomes (3)
Venham's Picture Test
Overall aceptability of the intervention
Measured: Within 1 hour of procedure
Parental Emotional Stress Questionnaire
Measured: Within 1 hour of procedure
Recall questionnaire
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startOct 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Hospital, India
- Sponsor type
- Other government
- Collaborators
- Lata Medical Research Foundation, Nagpur
- Responsible party
- Principal investigator, Shweta Ujaoney, Government Dental College and Hospital, India
- Investigators
- Vinay K Hazarey, MDS, Study chair, Government Dental College and Hospital, IndiaJyoti Tote, MDS, Study director, Government Dental College and Hospital, IndiaPushpa V Hazarey, MDS, Study director, Government Dental College and Hospital, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398007
- Sponsor's protocol ID
- SUT2503
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Camouflage Syringe in Reducing Dental Anxiety and Fear in Children
- ClinicalTrials.gov ID
- NCT01398007
- Acronym / sponsor ID
- SUT2503
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Government Dental College and Hospital, IndiaOther government
- Collaborators
- Lata Medical Research Foundation, Nagpur
- Study start
- Oct 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional syringe | No intervention | –Conventional syringe |
| Camouflage syringe | Experimental | Procedure: Camouflage syringeThe 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. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children reporting to study center with dental problems
- Dental procedure requiring local anesthesia
- Informed consent from the parents
Key exclusion criteria (2 listed)
- Mentally challenged children
- Medical problems negating use of local anesthesia and/or surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camouflage syringeDental anesthesia is administered using the camouflaged syringe. | Procedure or surgery | Camouflage syringe |
Primary outcome
Venham's clinical rating scale
Time frame: Within 1 hour of procedure
Venham's clinical rating scale for movement, crying and overall behavior
3 secondary outcomes
Venham's Picture Test
Time frame: Within 1 hour of procedure
Parental Emotional Stress Questionnaire
Time frame: Within 1 hour of procedure
Recall questionnaire
Time frame: Within 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay K Hazarey, MDS study chair
Government Dental College and Hospital, India
Jyoti Tote, MDS study director
Government Dental College and Hospital, India
Pushpa V Hazarey, MDS study director
Government Dental College and Hospital, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camouflage syringe in people with Anxiety and Fear, run by Government Dental College and Hospital, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venham's clinical rating scale (time frame: Within 1 hour of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.