Dental Anxiety in ChildrenNCT07571421
Effect of a Visual Educational Intervention on Dental Anxiety in Children
A study testing Visual Educational Leaflet in people with Dental Anxiety in Children, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety in Children
- What is being tested?
- Visual Educational Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 31 Jul 2021
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5 to 14 years
- Requiring restorative dental treatment
- No systemic disease
- No mental or physical disabilities
- Not using medications that could affect anxiety assessment
- Having previous dental experience (i.e., not first dental visit)
Who cannot join
- Children attending their first dental visit
- Children with a documented history of definitely negative or negative behavior (Frankl score 1-2)
- Participants with incomplete data
- Participants who withdrew consent at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, 34188
About this study
Official title: Effect of a Visual Pedagogical Intervention on Anticipatory Dental Anxiety in Children: A Randomized Controlled Trial
This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients.
A total of 70 children aged 5 to 14 years were randomly assigned to either a study group that received a visual educational introduction to the dental environment or a control group that received standard care. Dental anxiety was assessed using validated scales and pulse rate measurements.
Read more
The results showed that children who received the visual educational intervention had lower anxiety levels and reduced physiological stress compared to the control group. The effect was more pronounced in older children, suggesting that age and cognitive development play an important role in the effectiveness of such interventions.
Overall, this simple and non-invasive approach may help reduce dental anxiety in children and improve their experience during dental visits.
Read the detailed description
The COVID-19 pandemic introduced significant changes to the dental clinical environment, particularly due to the widespread use of personal protective equipment (PPE), which may increase anxiety in pediatric patients. Dental anxiety is a common and multifactorial condition in children and can negatively affect cooperation, treatment outcomes, and overall oral health. Therefore, effective and non-invasive strategies to reduce anticipatory anxiety are essential in pediatric dentistry.
This randomized controlled clinical trial aimed to evaluate the effectiveness of a structured visual educational intervention in reducing anticipatory dental anxiety and physiological responses in children aged 5 to 14 years undergoing restorative dental treatment. The intervention was specifically designed to familiarize children with the dental environment and the appearance of dental professionals during the COVID-19 pandemic.
Participants were randomly assigned in a 1:1 ratio to either an intervention group or a control group using a computer-generated randomization sequence. Allocation concealment was ensured through the use of sequentially numbered, opaque, sealed envelopes. Due to the nature of the intervention, participant blinding was not feasible. However, outcome assessment was performed by a trained pediatric dentist who was blinded to group allocation.
The visual educational intervention consisted of a structured leaflet developed according to visual pedagogy principles. The material included child-friendly images illustrating dental professionals with and without PPE, common dental instruments, and the dental clinical environment. The aim was to provide anticipatory guidance and reduce uncertainty by presenting information in a simple and age-appropriate format.
Children in the intervention group received the visual educational material in the waiting area prior to treatment and were given time to review it with their parents. The control group received standard clinical care without additional preparatory intervention.
Dental anxiety was assessed using validated self-report measures, including the faces version of the Modified Child Dental Anxiety Scale (MCDASf) and the Facial Image Scale (FIS). In addition, physiological response to anxiety was evaluated by measuring pulse rate using a pulse oximeter. All outcome assessments were performed prior to the initiation of dental treatment.
To explore potential differences in intervention effectiveness, subgroup analyses were conducted based on age groups (5-7, 8-10, and 11-14 years) and sex. These groupings were selected to reflect differences in cognitive development, which may influence how children process and respond to visual information.
This study provides insight into the potential role of visual educational strategies as a simple, low-cost, and non-invasive method to reduce anticipatory dental anxiety in pediatric patients, particularly in the context of altered clinical environments such as those observed during the COVID-19 pandemic.
- Conditions
- Dental Anxiety in Children
- Being tested
- Visual Educational Leaflet
- Keywords
- COVID-19; dental anxiety; pediatric dentistry; heart rate; patient education; randomized controlled trial.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Educational LeafletBehavioural
A structured visual educational leaflet designed to familiarise children with the dental clinical environment and personal protective equipment. The material included child-friendly images of dental staff, equipment, and procedures to reduce anticipatory dental anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Visual Educational Intervention Group | Experimental | Participants received a visual educational leaflet introducing the dental environment and personal protective equipment before treatment. Receives: Behavioral: Visual Educational Leaflet |
| Control group | No intervention | Participants received standard clinical care without any additional preparatory intervention before treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Dental Anxiety (MCDASf)
Dental anxiety was assessed using the faces version of the Modified Child Dental Anxiety Scale (MCDASf). The scale consists of 8 items scored from 1 to 5, with a total score range of 8 to 40. Higher scores indicate greater levels of dental anxiety.
Measured: Immediately before dental treatment (pre-treatment assessment)
Self-Reported Dental Anxiety (FIS)
Dental anxiety was assessed using the Facial Image Scale (FIS), which consists of 5 facial expressions scored from 1 (very happy) to 5 (very unhappy). Higher scores indicate greater levels of anxiety.
Measured: Immediately before dental treatment (pre-treatment assessment)
Secondary outcomes (1)
Physiological Anxiety Response (Pulse Rate)
Physiological response to dental anxiety was assessed by measuring pulse rate (beats per minute, bpm) using a pulse oximeter device. Higher values indicate greater physiological arousal associated with anxiety.
Measured: Immediately before dental treatment (pre-treatment assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Mar 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a visual educational intervention group or a control group receiving standard care. The two groups were followed in parallel and compared in terms of dental anxiety outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Pınar Erdem, Istanbul University
- Investigators
- Arzu P Erdem, Principle Investigator, Study director, Istanbul University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571421
- Sponsor's protocol ID
- IUFD-2021/53
- Other IDs
- TLO-2021-38364
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations, as the study involves pediatric participants and consent for data sharing was not obtained.
Publications
Cirio S, Salerno C, Mbanefo S, Oberti L, Paniura L, Campus G, Cagetti MG. Use of Visual Pedagogy to Help Children with ASDs Facing the First Dental Examination: A Randomized Controlled Trial. Children (Basel). 2022 May 16;9(5):729. doi: 10.3390/children9050729.
PubMed 35626906Dogan MC, Seydaoglu G, Uguz S, Inanc BY. The effect of age, gender and socio-economic factors on perceived dental anxiety determined by a modified scale in children. Oral Health Prev Dent. 2006;4(4):235-41.
PubMed 17153645Giri S, Saha S, Dhinsa K, Yadav G, Sharma A, Pradhan S. Comparative Evaluation of Behavioral and Physiological Outcomes on Dental Anxiety of Children Undergoing Dental Treatment: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2025 Apr;18(4):383-393. doi: 10.5005/jp-journals-10005-3088. Epub 2025 May 19.
PubMed 40469821
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Visual Pedagogical Intervention on Anticipatory Dental Anxiety in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07571421
- Acronym / sponsor ID
- IUFD-2021/53
- Conditions
- Dental Anxiety in Children
- Keywords
- COVID-19; dental anxiety; pediatric dentistry; heart rate; patient education; randomized controlled trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 6 May 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.
This study evaluated whether a visual educational intervention could reduce dental anxiety in children. During the COVID-19 pandemic, changes in the dental environment, including the use of personal protective equipment, may have increased anxiety levels in pediatric patients.
A total of 70 children aged 5 to 14 years were randomly assigned to either a study group that received a visual educational introduction to the dental environment or a control group that received standard care. Dental anxiety was assessed using validated scales and pulse rate measurements.
The results showed that children who received the visual educational intervention had lower anxiety levels and reduced physiological stress compared to the control group. The effect was more pronounced in older children, suggesting that age and cognitive development play an important role in the effectiveness of such interventions.
Overall, this simple and non-invasive approach may help reduce dental anxiety in children and improve their experience during dental visits.
Detailed description
The COVID-19 pandemic introduced significant changes to the dental clinical environment, particularly due to the widespread use of personal protective equipment (PPE), which may increase anxiety in pediatric patients. Dental anxiety is a common and multifactorial condition in children and can negatively affect cooperation, treatment outcomes, and overall oral health. Therefore, effective and non-invasive strategies to reduce anticipatory anxiety are essential in pediatric dentistry.
This randomized controlled clinical trial aimed to evaluate the effectiveness of a structured visual educational intervention in reducing anticipatory dental anxiety and physiological responses in children aged 5 to 14 years undergoing restorative dental treatment. The intervention was specifically designed to familiarize children with the dental environment and the appearance of dental professionals during the COVID-19 pandemic.
Participants were randomly assigned in a 1:1 ratio to either an intervention group or a control group using a computer-generated randomization sequence. Allocation concealment was ensured through the use of sequentially numbered, opaque, sealed envelopes. Due to the nature of the intervention, participant blinding was not feasible. However, outcome assessment was performed by a trained pediatric dentist who was blinded to group allocation.
The visual educational intervention consisted of a structured leaflet developed according to visual pedagogy principles. The material included child-friendly images illustrating dental professionals with and without PPE, common dental instruments, and the dental clinical environment. The aim was to provide anticipatory guidance and reduce uncertainty by presenting information in a simple and age-appropriate format.
Children in the intervention group received the visual educational material in the waiting area prior to treatment and were given time to review it with their parents. The control group received standard clinical care without additional preparatory intervention.
Dental anxiety was assessed using validated self-report measures, including the faces version of the Modified Child Dental Anxiety Scale (MCDASf) and the Facial Image Scale (FIS). In addition, physiological response to anxiety was evaluated by measuring pulse rate using a pulse oximeter. All outcome assessments were performed prior to the initiation of dental treatment.
To explore potential differences in intervention effectiveness, subgroup analyses were conducted based on age groups (5-7, 8-10, and 11-14 years) and sex. These groupings were selected to reflect differences in cognitive development, which may influence how children process and respond to visual information.
This study provides insight into the potential role of visual educational strategies as a simple, low-cost, and non-invasive method to reduce anticipatory dental anxiety in pediatric patients, particularly in the context of altered clinical environments such as those observed during the COVID-19 pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a visual educational intervention group or a control group receiving standard care. The two groups were followed in parallel and compared in terms of dental anxiety outcomes.
| Arm | Type | Receives |
|---|---|---|
| Visual Educational Intervention Group | Experimental | Behavioral: Visual Educational LeafletParticipants received a visual educational leaflet introducing the dental environment and personal protective equipment before treatment. |
| Control group | No intervention | –Participants received standard clinical care without any additional preparatory intervention before treatment. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 5 to 14 years
- Requiring restorative dental treatment
- No systemic disease
- No mental or physical disabilities
- Not using medications that could affect anxiety assessment
Key exclusion criteria (4 listed)
- Children attending their first dental visit
- Children with a documented history of definitely negative or negative behavior (Frankl score 1-2)
- Participants with incomplete data
- Participants who withdrew consent at any stage of the study
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 |
|---|---|---|
| Visual Educational LeafletA structured visual educational leaflet designed to familiarise children with the dental clinical environment and personal protective equipment. The material included child-friendly images of dental staff, equipment, and procedures to reduce anticipatory dental anxiety. | Behavioural | Visual Educational Intervention Group |
Primary outcome
Self-Reported Dental Anxiety (MCDASf)
Time frame: Immediately before dental treatment (pre-treatment assessment)
Dental anxiety was assessed using the faces version of the Modified Child Dental Anxiety Scale (MCDASf). The scale consists of 8 items scored from 1 to 5, with a total score range of 8 to 40. Higher scores indicate greater levels of dental anxiety.
Self-Reported Dental Anxiety (FIS)
Time frame: Immediately before dental treatment (pre-treatment assessment)
Dental anxiety was assessed using the Facial Image Scale (FIS), which consists of 5 facial expressions scored from 1 (very happy) to 5 (very unhappy). Higher scores indicate greater levels of anxiety.
1 secondary outcome
Physiological Anxiety Response (Pulse Rate)
Time frame: Immediately before dental treatment (pre-treatment assessment)
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 6 May 2026.
- Background: PubMed 35626906Cirio S, Salerno C, Mbanefo S, Oberti L, Paniura L, Campus G, Cagetti MG. Use of Visual Pedagogy to Help Children with ASDs Facing the First Dental Examination: A Randomized Controlled Trial. Children (Basel). 2022 May 16;9(5):729. doi: 10.3390/children9050729.
- Background: PubMed 17153645Dogan MC, Seydaoglu G, Uguz S, Inanc BY. The effect of age, gender and socio-economic factors on perceived dental anxiety determined by a modified scale in children. Oral Health Prev Dent. 2006;4(4):235-41.
- Background: PubMed 40469821Giri S, Saha S, Dhinsa K, Yadav G, Sharma A, Pradhan S. Comparative Evaluation of Behavioral and Physiological Outcomes on Dental Anxiety of Children Undergoing Dental Treatment: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2025 Apr;18(4):383-393. doi: 10.5005/jp-journals-10005-3088. Epub 2025 May 19.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations, as the study involves pediatric participants and consent for data sharing was not obtained.
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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.
Arzu P Erdem, Principle Investigator study director
Istanbul University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Educational Leaflet in people with Dental Anxiety in Children, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 6 May 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 Turkey (Türkiye). 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?
Self-Reported Dental Anxiety (MCDASf) (time frame: Immediately before dental treatment (pre-treatment assessment)). 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 NCT07571421, which also lists 3 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 6 May 2026.