Dental AnxietyNCT07715539
The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial
A study testing Video modelling group in people with Dental Anxiety, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Video modelling group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2025to 3 Mar 2026
- 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
Who may be able to join
- Medically healthy children classified as American Society of Anesthesiologists (ASA) physical status I or II.
- Age 4-6 years.
- Children presenting to the JUST postgraduate paediatric dental clinic with no previous dental visits.
Who cannot join
- Children with systemic medical conditions or with mental, cognitive, or intellectual disabilities.
- Children with visual or hearing impairments.
- Participants unwilling to complete subjective anxiety assessment scales due to elevated anxiety levels.
- Children whose parents are unable to read or write.
- Participants without access to internet services.
- Children presenting with severe active dental pain and/or facial abscess, as these conditions may influence state anxiety.
- Children with previous dental experience.
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction.
Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.
Read the detailed description
Background: The first dental visit can be a very challenging experience for children, and anxiety at this stage may influence behaviour during treatment and future dental attendance.
Non-pharmacological interventions such as animated video modelling may help reduce preoperative anxiety.
Aim: The primary aim of this study was to evaluate the efficacy of a cartoon animated video-modelling intervention in reducing preoperative anxiety among preschool children during their first dental visit. The secondary aim was to assess the effect of the intervention on parental anxiety.
Methods: This single-blinded randomised controlled trial was conducted at the Postgraduate Paediatric Dental Clinic at Jordan University of Science and Technology.
Ninety-four healthy children aged 4-6 years with no previous dental experience were randomly allocated to a video-modelling group or a control group (n = 47 per group).
Expected results: The study predicts animated videos will lower children's preoperative anxiety and improve the overall dental experience for both parent and child. This could lead to video modeling being used in pediatric dentistry, especially for low-income families, to reduce anxiety and improve patient outcomes.
- Conditions
- Dental Anxiety
- Being tested
- Video modelling group
- Keywords
- Dental anxiety, behavioral guidance, pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video modelling groupBehavioural
The cartoon-animated video followed a child character's journey from home to arrival at the clinic, introduction to the dentist, and progression through the dental visit. The video showed the child character progressing through the main stages of a routine dental visit, including seating in the dental chair, intra-oral examination, radiographic assessment in the radiography room, and preventive procedures.
| Study group | Role | What they receive |
|---|---|---|
| video-modelling group | Experimental | Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit. Receives: Behavioral: Video modelling group |
| Control group | No intervention | Children in the control group received routine care upon arrival at the clinic, which consisted of a verbal explanation of the planned procedures while in the waiting area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale
Children's anxiety was assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), an observational behavioural scale evaluating anxiety-related behaviours across five domains: activity, vocalization, emotional expressivity, state of apparent arousal, and use of parents. Scores range from 23.33 to 100, with higher scores indicating greater anxiety. Assessments were conducted by a blinded research assistant upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5).
Measured: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Change in children's anxiety scores measured using the Visual Facial Anxiety Scale (VFAS)
Children's self-reported anxiety was assessed using the Visual Facial Anxiety Scale (VFAS), a validated scale consisting of facial expressions representing increasing levels of anxiety. Children selected the face that best reflects their anxiety level at each time point. Assessments were conducted at baseline (T1), upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the procedure (T4), and 10-15 minutes after completion of the procedure (T5). Scores range from 0 to 5, with higher scores indicating greater anxiety.
Measured: Baseline (day prior to dental visit) through 10-15 minutes post-procedure
Secondary outcomes (1)
Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale
Parental anxiety was assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-State), which measures situational anxiety at the time of assessment. Scores range from 20 to 80, with higher scores indicating greater anxiety. Parents completed the questionnaire on the day before the dental appointment (T1) and again 10-15 minutes after completion of the child's dental procedure (T5).
Measured: Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Feb 2025
- Primary completion1 Dec 2025
- Study completion3 Mar 2026
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 Dental 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mawia Bataineh, Study director, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715539
- Sponsor's protocol ID
- 20240602
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on the institution's policy on sharing results
Publications
Bahammam MA. Validity and reliability of an Arabic version of the state-trait anxiety inventory in a Saudi dental setting. Saudi Med J. 2016 Jun;37(6):668-74. doi: 10.15537/Smj.2016.6.13935.
PubMed 27279514
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07715539
- Acronym / sponsor ID
- 20240602
- Conditions
- Dental Anxiety
- Keywords
- Dental anxiety, behavioral guidance, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 20 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 primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction.
Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.
Detailed description
Background: The first dental visit can be a very challenging experience for children, and anxiety at this stage may influence behaviour during treatment and future dental attendance.
Non-pharmacological interventions such as animated video modelling may help reduce preoperative anxiety.
Aim: The primary aim of this study was to evaluate the efficacy of a cartoon animated video-modelling intervention in reducing preoperative anxiety among preschool children during their first dental visit. The secondary aim was to assess the effect of the intervention on parental anxiety.
Methods: This single-blinded randomised controlled trial was conducted at the Postgraduate Paediatric Dental Clinic at Jordan University of Science and Technology.
Ninety-four healthy children aged 4-6 years with no previous dental experience were randomly allocated to a video-modelling group or a control group (n = 47 per group).
Expected results: The study predicts animated videos will lower children's preoperative anxiety and improve the overall dental experience for both parent and child. This could lead to video modeling being used in pediatric dentistry, especially for low-income families, to reduce anxiety and improve patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video-modelling group | Experimental | Behavioral: Video modelling groupChildren allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit. |
| Control group | No intervention | –Children in the control group received routine care upon arrival at the clinic, which consisted of a verbal explanation of the planned procedures while in the waiting area. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Medically healthy children classified as American Society of Anesthesiologists (ASA) physical status I or II.
Key exclusion criteria (7 listed)
- Children with systemic medical conditions or with mental, cognitive, or intellectual disabilities.
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 |
|---|---|---|
| Video modelling groupThe cartoon-animated video followed a child character's journey from home to arrival at the clinic, introduction to the dentist, and progression through the dental visit. The video showed the child character progressing through the main stages of a routine dental visit, including seating in the dental chair, intra-oral examination, radiographic assessment in the radiography room, and preventive procedures. | Behavioural | video-modelling group |
Primary outcome
Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale
Time frame: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Children's anxiety was assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), an observational behavioural scale evaluating anxiety-related behaviours across five domains: activity, vocalization, emotional expressivity, state of apparent arousal, and use of parents. Scores range from 23.33 to 100, with higher scores indicating greater anxiety. Assessments were conducted by a blinded research assistant upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5).
Change in children's anxiety scores measured using the Visual Facial Anxiety Scale (VFAS)
Time frame: Baseline (day prior to dental visit) through 10-15 minutes post-procedure
Children's self-reported anxiety was assessed using the Visual Facial Anxiety Scale (VFAS), a validated scale consisting of facial expressions representing increasing levels of anxiety. Children selected the face that best reflects their anxiety level at each time point. Assessments were conducted at baseline (T1), upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the procedure (T4), and 10-15 minutes after completion of the procedure (T5). Scores range from 0 to 5, with higher scores indicating greater anxiety.
1 secondary outcome
Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale
Time frame: Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
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 20 Jul 2026.
- Background: PubMed 27279514Bahammam MA. Validity and reliability of an Arabic version of the state-trait anxiety inventory in a Saudi dental setting. Saudi Med J. 2016 Jun;37(6):668-74. doi: 10.15537/Smj.2016.6.13935.
- American Academy of Pediatric DentistryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It depends on the institution's policy on sharing results
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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.
Mawia Bataineh study director
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video modelling group in people with Dental Anxiety, run by Jordan University of Science and Technology at 1 site in Jordan.
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 7 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 20 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 Jordan. 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?
Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale (time frame: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)). 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?
On the ClinicalTrials.gov record for NCT07715539, 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 20 Jul 2026.