Dental Anxiety in ChildrenNCT07736170
Effectiveness of Puppet Modeling During Dental Emergency Visits on Dental Anxiety and Behavior of Children in a Subsequent Visit
A study testing Puppet Play Therapy and Tell-Show-Do (TSD) in people with Dental Anxiety in Children, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are: Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?… Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety in Children
- What is being tested?
- Puppet Play Therapy and Tell-Show-Do (TSD)
- 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 siteSaudi Arabia
- Study dates
- 1 Feb 2024to 30 Jun 2025
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy (including healthy children presenting with a localized dental abscess and no systemic involvement),
- Arabic-speaking
- and required emergency dental treatment under local anesthesia
Who cannot join
- ASA II or higher according to the American Society of Anesthesiologists Physical Status Classification,
- or if they required advanced behavior guidance, such as protective stabilization, during the emergency visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Puppet-Aided Tell-Show-Do During Dental Emergency Visit on Dental Anxiety and Behavior of Children in a Subsequent Visit: A Randomized Clinical Trial
The goal of this clinical trial is to learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are:
- Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?
- Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit?
Read more
Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior.
Participants were randomly allocated into two groups:
- Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit.
- Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.
- Conditions
- Dental Anxiety in Children
- Being tested
- Puppet Play Therapy, Tell-Show-Do (TSD)
- Keywords
- behavior management, dental anxiety, pediatric dentistry, puppet, tell-show-do
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puppet Play TherapyBehavioural
Also called Puppet Guidance
The investigator used the puppet to interact with the participants and explain the treatment in simple language before starting the dental procedure.
Tell-Show-Do (TSD)Behavioural
Tell: The dentist explained what is about to happen using simple, age-appropriate language.
Show: The dentist demonstrated the tool outside of the patient's mouth. Do: The dentist performed the procedure in the patient's mouth exactly as described.
| Study group | Role | What they receive |
|---|---|---|
| Puppet-aided TSD | Experimental | Children who received puppet-aided tell-show-do as a behavior guidance technique in the emergency dental visit. Receives: Behavioral: Puppet Play Therapy |
| TSD | Active comparator | Children who received traditional tell-show-do as a behavior guidance technique in the emergency dental visit. Receives: Behavioral: Tell-Show-Do (TSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years
The scale consists of eight pairs of images, each showing a child in both anxious and calm states. Children are asked to select one image from each pair that best represents how they feel. Each anxious image chosen is scored as one, while calm selections are scored as zero. The total dental anxiety score, which ranges from zero to eight, is calculated by summing the individual scores, with higher totals indicating greater anxiety.
Measured: 2 weeks after the intervention
Subjective Dental Anxiety as Assessed by Abeer Children Dental Anxiety Scale (ACDAS) for Children Aged 6-9 Years
The scale is divided into three sections. Part A includes 13 self-reported items presented in a logical sequence, in which children indicate their feelings toward different dental situations using three facial expressions: happy/relaxed (score = 1), neutral/ "OK" (score = 2), and scared/anxious (score = 3). The total score ranges from 13 to 39; scores ≥26 indicate significant dental anxiety. Part B consists of three yes/no questions exploring the child's cognitive concerns, such as shyness about their teeth or dentist, and fear of losing control during treatment. Part C gathers additional information from both the parent/guardian and the dentist: parents report on the child's previous dental experiences and anticipated behavior, while the dentist records the child's behavior after treatment. By combining self-reported, parental, and clinical perspectives, ACDAS provides a comprehensive assessment of dental anxiety in children
Measured: 2 weeks after the intervention
Objective Dental Anxiety as Assessed by the Venham Anxiety Rating Scale (VARS)
The VARS is constructed of six behaviorally defined categories that range from zero to five, with higher scores indicating higher levels of dental anxiety. The score gradually increases from relaxed (Score 0), to the child is totally out of control (Score 5). The target population for this scale is children aged 3-12 years.
Measured: 2 weeks after the intervention
Behavior as Assessed by the Behavior Profile Rating Scale (BPRS)
An independent observer, other than the operating dentist, is required to systematically record the occurrence of 27 distinct behavioral aspects over a series of 3-minute intervals. Four of these behaviors assess the child's reaction to his separation from a parent. The remaining 23 aspects assess the child's behavior in the dental office. Each behavior is assigned a weighted score that reflects its level of disruptiveness. The total score is calculated by multiplying the frequency of each behavior during the 3-minute periods by its weight, then summing the results across all categories and dividing by the number of intervals.
In this study, the BPRS was adapted to be applied once per quadrant during oral prophylaxis, rather than at fixed 3-minute intervals, because the procedure was short and, in some cases, did not extend to three minutes.
Measured: 2 weeks after the intervention
Secondary outcomes (1)
Behavior as Assessed by the Frankl Behavior Rating Scale (FBRS)
This scale classifies patient behavior into four specific categories.:Definitely Negative (Rating 1): The child completely refuses treatment, cries forcefully, shows extreme fear, or displays overt negativism.Negative (Rating 2): The child is reluctant to accept treatment and uncooperative, but there is no extreme negativism (e.g., no forceful crying or treatment refusal).Positive (Rating 3): The child accepts treatment and is generally willing to comply with the dentist's directions, though they may be a bit cautious or reserved.Definitely Positive (Rating 4): The child has excellent rapport with the dentist, shows genuine interest in the procedure, laughs, and enjoys the visit.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Feb 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Anxiety in ChildrenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Aldajani, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736170
- Sponsor's protocol ID
- 119-06-23
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request.
Publications
Athanassiadou E, Giannakopoulos G, Kolaitis G, Tsiantis J, Christogiorgos S. Preparing the child facing surgery: The use of play therapy. Psychoanalytic social work. 2012;19(1-2):91-100.
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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Puppet-Aided Tell-Show-Do During Dental Emergency Visit on Dental Anxiety and Behavior of Children in a Subsequent Visit: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07736170
- Acronym / sponsor ID
- 119-06-23
- Conditions
- Dental Anxiety in Children
- Keywords
- behavior management, dental anxiety, pediatric dentistry, puppet, tell-show-do
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Jul 2026 (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 learn if using a puppet in dental visits for children is an effective behavior guidance tool. The main questions it aims to answer are:
- Does using a puppet to explain dental procedures to children during emergency dental visits lower their anxiety in a subsequent dental visit?
- Does using a puppet to explain dental procedures to children during emergency dental visits improve their behavior in a subsequent dental visit?
Researchers compared the effect of using a puppet to the traditional tell-show-do behavior guidance technique to see if the puppet is more effective in lowering their anxiety and improving their behavior.
Participants were randomly allocated into two groups:
- Group I: Children who received puppet play therapy in the emergency dental visit and in the subsequent dental visit.
- Group II: Children who received only the traditional tell-show-do behavior guidance technique in the emergency dental visit and in the subsequent dental visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puppet-aided TSD | Experimental | Behavioral: Puppet Play TherapyChildren who received puppet-aided tell-show-do as a behavior guidance technique in the emergency dental visit. |
| TSD | Active comparator | Behavioral: Tell-Show-Do (TSD)Children who received traditional tell-show-do as a behavior guidance technique in the emergency dental visit. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy (including healthy children presenting with a localized dental abscess and no systemic involvement),
- Arabic-speaking
- and required emergency dental treatment under local anesthesia
Key exclusion criteria (2 listed)
- ASA II or higher according to the American Society of Anesthesiologists Physical Status Classification,
- or if they required advanced behavior guidance, such as protective stabilization, during the emergency visit.
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 |
|---|---|---|
| Puppet Play TherapyAlso: Puppet GuidanceThe investigator used the puppet to interact with the participants and explain the treatment in simple language before starting the dental procedure. | Behavioural | Puppet-aided TSD |
| Tell-Show-Do (TSD)Tell: The dentist explained what is about to happen using simple, age-appropriate language. Show: The dentist demonstrated the tool outside of the patient's mouth. Do: The dentist performed the procedure in the patient's mouth exactly as described. | Behavioural | TSD |
Primary outcome
Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years
Time frame: 2 weeks after the intervention
The scale consists of eight pairs of images, each showing a child in both anxious and calm states. Children are asked to select one image from each pair that best represents how they feel. Each anxious image chosen is scored as one, while calm selections are scored as zero. The total dental anxiety score, which ranges from zero to eight, is calculated by summing the individual scores, with higher totals indicating greater anxiety.
Subjective Dental Anxiety as Assessed by Abeer Children Dental Anxiety Scale (ACDAS) for Children Aged 6-9 Years
Time frame: 2 weeks after the intervention
The scale is divided into three sections. Part A includes 13 self-reported items presented in a logical sequence, in which children indicate their feelings toward different dental situations using three facial expressions: happy/relaxed (score = 1), neutral/ "OK" (score = 2), and scared/anxious (score = 3). The total score ranges from 13 to 39; scores ≥26 indicate significant dental anxiety. Part B consists of three yes/no questions exploring the child's cognitive concerns, such as shyness about their teeth or dentist, and fear of losing control during treatment. Part C gathers additional information from both the parent/guardian and the dentist: parents report on the child's previous dental experiences and anticipated behavior, while the dentist records the child's behavior after treatment. By combining self-reported, parental, and clinical perspectives, ACDAS provides a comprehensive assessment of dental anxiety in children
Objective Dental Anxiety as Assessed by the Venham Anxiety Rating Scale (VARS)
Time frame: 2 weeks after the intervention
The VARS is constructed of six behaviorally defined categories that range from zero to five, with higher scores indicating higher levels of dental anxiety. The score gradually increases from relaxed (Score 0), to the child is totally out of control (Score 5). The target population for this scale is children aged 3-12 years.
Behavior as Assessed by the Behavior Profile Rating Scale (BPRS)
Time frame: 2 weeks after the intervention
An independent observer, other than the operating dentist, is required to systematically record the occurrence of 27 distinct behavioral aspects over a series of 3-minute intervals. Four of these behaviors assess the child's reaction to his separation from a parent. The remaining 23 aspects assess the child's behavior in the dental office. Each behavior is assigned a weighted score that reflects its level of disruptiveness. The total score is calculated by multiplying the frequency of each behavior during the 3-minute periods by its weight, then summing the results across all categories and dividing by the number of intervals. In this study, the BPRS was adapted to be applied once per quadrant during oral prophylaxis, rather than at fixed 3-minute intervals, because the procedure was short and, in some cases, did not extend to three minutes.
1 secondary outcome
Behavior as Assessed by the Frankl Behavior Rating Scale (FBRS)
Time frame: immediately after the procedure
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 30 Jul 2026.
- Results publicationAthanassiadou E, Giannakopoulos G, Kolaitis G, Tsiantis J, Christogiorgos S. Preparing the child facing surgery: The use of play therapy. Psychoanalytic social work. 2012;19(1-2):91-100.
- Results publication: 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.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request.
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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 Puppet Play Therapy and Tell-Show-Do (TSD) in people with Dental Anxiety in Children, 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 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 30 Jul 2026. 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?
Subjective Dental Anxiety as Assessed by Venham Picture Test (VPT) for Children Aged 3-5 Years (time frame: 2 weeks after the intervention). The study lists 4 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 NCT07736170, which also lists 2 linked publications.
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 30 Jul 2026.