Behavioral Guidance in Pediatric DentistryNCT06326307
Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures
A study testing Tell Show and Do Guidance and Puppet Guidance in people with Behavioral Guidance in Pediatric Dentistry, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures' The main question[s] it aims to answer are: 1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Guidance in Pediatric Dentistry
- What is being tested?
- Tell Show and Do Guidance and Puppet Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2023to 1 Dec 2023
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children having no previous experience of local anesthesia
- Children aged 3-8 years old
- Children with negative history of any particular underlying disease.
Who cannot join
- • Children who needed procedures with no local anesthesia.
- Children who were allergic to local anesthesia.
- Children who were indicated for advanced behavioral guidance.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abulaziz university dental hospital
Jeddah, Mecca Region, 21589
About this study
Official title: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures' Randomized Clinical Crossover Trial
The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'
- The main question[s] it aims to answer are:
Read more
- To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
- To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia. type of study: clinical trial participant population/health conditions: Healthy
In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:
- Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
- Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
Read the detailed description
Aim of the Study: The aim of this research is to compare the effectiveness of tell show and do (TSD) vs puppet play therapy on children's behavior during the administration of local anesthesia.
Materials and Methods: This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children (aged 3-7 years) randomly divided into two groups of. Group I (23 children): Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later. Group II (18 children): Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later. The anxiety level was determined using Facial Index Scale(FIS) and Venham anxiety rating scale and pulse rate (PR) at the beginning, middle and the end of each anesthesia administration. Patient behavior was also scored using Frankl behavior rating scale (FBRS) , Venham behavior rating scale. The FLACC scale was used to assess pain.
- Being tested
- Tell Show and Do Guidance, Puppet Guidance
- Keywords
- behavioral guidance, Pediatric dentistry, puppet, tell show and do
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell Show and Do GuidanceBehavioural
In this technique, the dentist tells explains the procedure using the Tell show and do method.
Puppet GuidanceBehavioural
In this technique, the dentist using the puppet to explains the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD) Receives: Behavioral: Tell Show and Do Guidance; Behavioral: Puppet Guidance |
| Group 2 | Experimental | Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) Receives: Behavioral: Tell Show and Do Guidance; Behavioral: Puppet Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
The heart rate was measured throughout the procedure using Gibson finger oximeter. Three readings were recorded. One before the administration of local anesthesia, one during the injection and one immediately after.
Measured: through study completion, an average of 1 year
Facial Image Scale
The FIS comprises a row of five faces ranging from (1) very happy to (5) very unhappy. It is simple, efficient measure of anxiety in very young children than other measures of anxiety that depend on the cognitive ability of the child
Measured: through study completion, an average of 1 year
Vehnam Anxiety Rating Scale
The Vehnam Anxiety Rating Scale was used in this clinical trial to measure the patient's situational dental anxiety. This scale is an interval rating scale with the interval ranging from 0 (the least anxious score) to 5 (the most anxious
Measured: through study completion, an average of 1 year
Frankl behavior rating scale
It classifies child behavior into four groups according to the child's attitude during dental treatment: (4)Definitely positive, (3) Positive, (2) Negative, and (1) Definitely negative.
Measured: through study completion, an average of 1 year
FLACC Pain scale
Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. Each category will be given a score ranging from 0 to 2. The final score is calculated by adding up the scores of the five categories for a final score out of 10.
Measured: through study completion, an average of 1 year
Venham Scale of Dental behavior
The Venham Scale of Dental behavior is an interval rating scale with the interval ranking from 0 (extremely cooperative) to 5 (extremely uncooperative).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral Guidance in Pediatric DentistryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD) * Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Layla Khogeer, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326307
- Sponsor's protocol ID
- 247-05-21
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
PubMed 40604606
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures' Randomized Clinical Crossover Trial
- ClinicalTrials.gov ID
- NCT06326307
- Acronym / sponsor ID
- 247-05-21
- Keywords
- behavioral guidance, Pediatric dentistry, puppet, tell show and do
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 22 Mar 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 RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'
- The main question[s] it aims to answer are:
- To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
- To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia. type of study: clinical trial participant population/health conditions: Healthy
In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:
- Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
- Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
Detailed description
Aim of the Study: The aim of this research is to compare the effectiveness of tell show and do (TSD) vs puppet play therapy on children's behavior during the administration of local anesthesia.
Materials and Methods: This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children (aged 3-7 years) randomly divided into two groups of. Group I (23 children): Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later. Group II (18 children): Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later. The anxiety level was determined using Facial Index Scale(FIS) and Venham anxiety rating scale and pulse rate (PR) at the beginning, middle and the end of each anesthesia administration. Patient behavior was also scored using Frankl behavior rating scale (FBRS) , Venham behavior rating scale. The FLACC scale was used to assess pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD) * Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Tell Show and Do Guidance, Behavioral: Puppet GuidanceChildren who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD) |
| Group 2 | Experimental | Behavioral: Tell Show and Do Guidance, Behavioral: Puppet GuidanceChildren who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Children having no previous experience of local anesthesia
Key exclusion criteria (3 listed)
- • Children who needed procedures with no local anesthesia.
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 |
|---|---|---|
| Tell Show and Do GuidanceIn this technique, the dentist tells explains the procedure using the Tell show and do method. | Behavioural | Group 1, Group 2 |
| Puppet GuidanceIn this technique, the dentist using the puppet to explains the procedure. | Behavioural | Group 1, Group 2 |
Primary outcome
Heart rate
Time frame: through study completion, an average of 1 year
The heart rate was measured throughout the procedure using Gibson finger oximeter. Three readings were recorded. One before the administration of local anesthesia, one during the injection and one immediately after.
Facial Image Scale
Time frame: through study completion, an average of 1 year
The FIS comprises a row of five faces ranging from (1) very happy to (5) very unhappy. It is simple, efficient measure of anxiety in very young children than other measures of anxiety that depend on the cognitive ability of the child
Vehnam Anxiety Rating Scale
Time frame: through study completion, an average of 1 year
The Vehnam Anxiety Rating Scale was used in this clinical trial to measure the patient's situational dental anxiety. This scale is an interval rating scale with the interval ranging from 0 (the least anxious score) to 5 (the most anxious
Frankl behavior rating scale
Time frame: through study completion, an average of 1 year
It classifies child behavior into four groups according to the child's attitude during dental treatment: (4)Definitely positive, (3) Positive, (2) Negative, and (1) Definitely negative.
FLACC Pain scale
Time frame: through study completion, an average of 1 year
Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. Each category will be given a score ranging from 0 to 2. The final score is calculated by adding up the scores of the five categories for a final score out of 10.
Venham Scale of Dental behavior
Time frame: through study completion, an average of 1 year
The Venham Scale of Dental behavior is an interval rating scale with the interval ranking from 0 (extremely cooperative) to 5 (extremely uncooperative).
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 22 Mar 2024.
- Derived from this study: PubMed 40604606Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.
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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 Tell Show and Do Guidance and Puppet Guidance in people with Behavioral Guidance in Pediatric Dentistry, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 3 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 22 Mar 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 Saudi Arabia. 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?
Heart rate (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326307, which also lists 1 linked publication.
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 22 Mar 2024.