AnxietyNCT06673030
Evaluation of the Effectiveness of New Management Techniques in Reducing Dental Anxiety for Children Undergoing Pulpotomy
A study testing Using Kaleidoscope glasses during pulpotomy procedures, The Play-Doh Doctor Drill 'n Fill toy set and Group 1 (Tell-Show-Do) in people with Anxiety, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Using Kaleidoscope glasses during pulpotomy procedures, The Play-Doh Doctor Drill 'n Fill toy set and Group 1 (Tell-Show-Do)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2023to 15 Sep 2024
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: 1. Children attended the dental clinic for their first time.
- Children aged between 4 to 6 years including both boys and girls. 3. Healthy Children with Frankl's behavior rating score 2,3 and 4 of Frankl's behavior rating scale and no prior dental experience.
- Children with carious lesions in lower restorable primary molars and indicated for pulpotomy.
- Exclusion Criteria: 1.Children with known significant visual impairments or psychological problems.
- Children suffering from systemic diseases or special health care needs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial
The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.
- Conditions
- Anxiety
- Being tested
- Using Kaleidoscope glasses during pulpotomy procedures, The Play-Doh Doctor Drill 'n Fill toy set, Group 1 (Tell-Show-Do)
- Keywords
- Childhood dental anxiety, Behavior management.
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Kaleidoscope glasses during pulpotomy proceduresBehavioural
Kaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface.
The Play-Doh Doctor Drill 'n Fill toy setBehavioural
Consists of a plastic human head with slots into which Play-doh molded teeth can be inserted. A battery operated toy drill is used to drill into and clean the black, cavitated tooth model and filled with white Play-Doh compound to simulate cavity preparation and restoration using tooth colored cement.
Group 1 (Tell-Show-Do)Other
In which Tell-Show-Do technique was done in three stages:
- Tell: The dental procedures were explained to the children using language and expressions appropriate for their age.
- Show: This began with showing the child the instruments and the topical anesthetic gel, high-speed handpiece and explaining the purpose of using the handpiece. and how the water removed using the suction device.
- Do: Performing the dental procedure immediately.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Tell-Show-Do) | Active comparator | Not described Receives: Other: Group 1 (Tell-Show-Do) |
| Group 2 ( Tell-Show-Play-Doh) | Experimental | Not described Receives: Behavioral: The Play-Doh Doctor Drill 'n Fill toy set |
| Group 3 (Kaleidoscope glasses ) | Experimental | Not described Receives: Behavioral: Using Kaleidoscope glasses during pulpotomy procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of behavior of the child before and during and after the pulpotomy procedures.
- Assessment of behavior of the child using ( Frankl's behavior rating scale to measure the cooperation behavior of the child, FLACC scale ).
- Frankl's behavior rating scale was used pre-operatively and post-operatively with 4 scores : score 1(Definitely negative) score 2(Negative) score 3(Positive) score 4 (Definitely positive), the best scores for positive attitude and cooperation are score 3, 4.
- The FLACC scale was used to measure behavior of the child according to Face, Legs, Activity, Cry and Consolability during the pulpotomy procedures with Scores: (0 = Relaxed and comfortable) (1-3 = Mild discomfort ) (4-6 = Moderate pain) (7-10 = Severe discomfort/pain).
Measured: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.
Assessment of anxiety of the child before and after the pulpotomy procedures.
- Assessment of anxiety of the child using (Pulse Oximeter to measure heart rate pre-operatively and post-operatively, RMS Pictorial Scale at the end of the visit). Increasing in heart rate readings means increasing anxiety.
- RMS Pictorial Scale which comprises a row of five faces ranging from score 1(very happy) to score 5 (very unhappy) and the children were asked to choose the face they felt like about themselves at that moment.
Measured: Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start5 Aug 2023
- Primary completion9 Mar 2024
- Study completion15 Sep 2024
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Yousef Mohamed Elmansy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673030
- Sponsor's protocol ID
- A01011023PP
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Kaleidoscope and Tell-Show-Play-Doh in Reducing Dental Anxiety for Children Undergoing Pulpotomy in Primary Molars - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06673030
- Acronym / sponsor ID
- A01011023PP
- Conditions
- Anxiety
- Keywords
- Childhood dental anxiety, Behavior management.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 9 Mar 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 4 Nov 2024 (actual)
- 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.
The goal of this clinical trial is to reduce dental anxiety for sixety six children undergoing pulpotomy in primary molars by using kaleidoscope glasses and Tell-Show-Play-Doh techniques and evaluation of behavior and anxiety achieved by using FLAAC scale, measuring heart rate and RMS-Pictorial scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Tell-Show-Do) | Active comparator | Other: Group 1 (Tell-Show-Do) |
| Group 2 ( Tell-Show-Play-Doh) | Experimental | Behavioral: The Play-Doh Doctor Drill 'n Fill toy set |
| Group 3 (Kaleidoscope glasses ) | Experimental | Behavioral: Using Kaleidoscope glasses during pulpotomy procedures |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Using Kaleidoscope glasses during pulpotomy proceduresKaleidoscope is an instrument that shows an infinite number of fascinating geometric shapes in the form of a flower, repeating and reflecting images of coloured goggle fragments in the front section in a prism mirroring the inner surface. | Behavioural | Group 3 (Kaleidoscope glasses ) |
| The Play-Doh Doctor Drill 'n Fill toy setConsists of a plastic human head with slots into which Play-doh molded teeth can be inserted. A battery operated toy drill is used to drill into and clean the black, cavitated tooth model and filled with white Play-Doh compound to simulate cavity preparation and restoration using tooth colored cement. | Behavioural | Group 2 ( Tell-Show-Play-Doh) |
| Group 1 (Tell-Show-Do)In which Tell-Show-Do technique was done in three stages: * Tell: The dental procedures were explained to the children using language and expressions appropriate for their age. * Show: This began with showing the child the instruments and the topical anesthetic gel, high-speed handpiece and explaining the purpose of using the handpiece. and how the water removed using the suction device. * Do: Performing the dental procedure immediately. | Other | Group 1 (Tell-Show-Do) |
Primary outcome
Assessment of behavior of the child before and during and after the pulpotomy procedures.
Time frame: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.
* Assessment of behavior of the child using ( Frankl's behavior rating scale to measure the cooperation behavior of the child, FLACC scale ). * Frankl's behavior rating scale was used pre-operatively and post-operatively with 4 scores : score 1(Definitely negative) score 2(Negative) score 3(Positive) score 4 (Definitely positive), the best scores for positive attitude and cooperation are score 3, 4. * The FLACC scale was used to measure behavior of the child according to Face, Legs, Activity, Cry and Consolability during the pulpotomy procedures with Scores: (0 = Relaxed and comfortable) (1-3 = Mild discomfort ) (4-6 = Moderate pain) (7-10 = Severe discomfort/pain).
Assessment of anxiety of the child before and after the pulpotomy procedures.
Time frame: Pre-operatively and post-operatively at the end of the visit at the same visit with no follow up.
* Assessment of anxiety of the child using (Pulse Oximeter to measure heart rate pre-operatively and post-operatively, RMS Pictorial Scale at the end of the visit). Increasing in heart rate readings means increasing anxiety. * RMS Pictorial Scale which comprises a row of five faces ranging from score 1(very happy) to score 5 (very unhappy) and the children were asked to choose the face they felt like about themselves at that moment.
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 4 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using Kaleidoscope glasses during pulpotomy procedures, The Play-Doh Doctor Drill 'n Fill toy set and Group 1 (Tell-Show-Do) in people with Anxiety, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Nov 2024. 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 Egypt. 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.
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?
Assessment of behavior of the child before and during and after the pulpotomy procedures. (time frame: Pre-operatively , during the procedure and post-operatively at the end of the visit at the same visit with no follow up.). The study lists 2 primary outcomes in all. 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 4 Nov 2024.