Preoperative AnxietyNCT07825493
Digital Storytelling-Based Animation for Preoperative Anxiety in Children
A study testing Digital Storytelling-Based Animation in people with Preoperative Anxiety and Dental Anxiety, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Preoperative Anxiety, Dental Anxiety
- What is being tested?
- Digital Storytelling-Based Animation
- Type of treatment
- Injection or infusion, 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
- 5 Jun 2026to 6 Aug 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-12 years. Children scheduled to undergo dental treatment under general anesthesia. Children whose parent or legal guardian provided written informed consent.
Who cannot join
- Children with a previous experience of general anesthesia. Children with chronic diseases. Children with cognitive, developmental, or communication impairments that could prevent understanding the digital animation or completing the anxiety assessments.
- Children whose parent or legal guardian did not provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Rize Province, 53100
About this study
Official title: Effect of Digital Storytelling-Based Animation on Preoperative Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
This randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Participants are randomly assigned to either an intervention group, which watches a digital storytelling-based animation before the procedure, or a control group receiving standard preoperative care. Anxiety is assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and Facial Image Scale (FIS). Physiological parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, are also evaluated. The study aims to determine whether the animation-based intervention reduces preoperative anxiety and physiological stress responses in children.
Read the detailed description
This study is a randomized controlled trial conducted with children aged 5-12 years scheduled to undergo dental treatment under general anesthesia. The study investigates whether a digital storytelling-based animation presented during the preoperative period can reduce children's anxiety and physiological stress responses.
Participants are randomly allocated to an intervention group or a control group. Children in the intervention group watch a digital storytelling-based animation before the procedure, whereas children in the control group receive standard preoperative care without the animation intervention.
Children's anxiety is evaluated using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and the Facial Image Scale (FIS) before and after the intervention. Physiological parameters, including heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation, are assessed at predefined time points during the perioperative period.
The primary objective is to evaluate the effect of the digital storytelling-based animation on preoperative anxiety. The secondary objective is to evaluate its effect on physiological parameters associated with the stress response.
- Conditions
- Preoperative Anxiety, Dental Anxiety
- Being tested
- Digital Storytelling-Based Animation
- Keywords
- Digital Storytelling, Animation, Preoperative Anxiety, Dental Anxiety, Pediatric Dentistry, General Anesthesia, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Storytelling-Based AnimationBehavioural
Children in the experimental group watched a digital storytelling-based animation during the preoperative period before intravenous access. The animation was designed to familiarize children with the perioperative process in an age-appropriate and engaging manner and to reduce preoperative anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Digital Storytelling-Based Animation Group | Experimental | Children assigned to this group received a digital storytelling-based animation intervention during the preoperative period before general anesthesia. The animation was administered before intravenous access and was designed to familiarize children with the perioperative process and reduce preoperative anxiety. In addition to the animation intervention, children received standard preoperative care. Receives: Behavioral: Digital Storytelling-Based Animation |
| Control Group | No intervention | Children assigned to the control group received standard preoperative care without the digital storytelling-based animation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Anxiety Measured by the Modified Child Dental Anxiety Scale-Faces (MCDAS-F)
Children's preoperative anxiety was assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F). The scale consists of 8 items, each scored from 1 to 5, resulting in a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. MCDAS-F scores were assessed before and after the digital storytelling-based animation intervention in the experimental group and at corresponding time points in the control group.
Measured: Immediately before and immediately after the intervention on the day of surgery
Secondary outcomes (5)
Change in Preoperative Anxiety Measured by the Facial Image Scale (FIS)
Children's preoperative anxiety was assessed using the Facial Image Scale (FIS). The FIS consists of five faces ranging from very happy to very unhappy and is scored from 1 to 5. Higher scores indicate greater anxiety. FIS scores were assessed before and after the intervention in the experimental group and at corresponding time points in the control group.
Measured: Immediately before and immediately after the intervention on the day of surgery
Change in Heart Rate
Heart rate was measured in beats per minute (bpm) at four predefined time points to evaluate physiological responses associated with preoperative anxiety and the intervention.
Measured: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) was measured using pulse oximetry and recorded as a percentage (%) at four predefined time points to evaluate physiological responses associated with preoperative anxiety and the intervention.
Measured: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Respiratory Rate
Respiratory rate was measured as the number of breaths per minute at four predefined time points to evaluate physiological responses associated with preoperative anxiety and the intervention.
Measured: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Blood Pressure
Systolic and diastolic blood pressure were measured in millimeters of mercury (mmHg) at four predefined time points to evaluate physiological responses associated with preoperative anxiety and the intervention.
Measured: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 Jun 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Boran, Recep Tayyip Erdogan University
- Investigators
- Serpil Boran, PhD, Principal investigator, Recep Tayyip Erdogan University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825493
- Sponsor's protocol ID
- RTEU-DSA-2026-01
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Storytelling-Based Animation on Preoperative Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07825493
- Acronym / sponsor ID
- RTEU-DSA-2026-01
- Conditions
- Preoperative Anxiety, Dental Anxiety
- Keywords
- Digital Storytelling, Animation, Preoperative Anxiety, Dental Anxiety, Pediatric Dentistry, General Anesthesia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 17 Sep 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 randomized controlled trial evaluates the effect of a digital storytelling-based animation on preoperative anxiety and physiological parameters in children aged 5-12 years undergoing dental treatment under general anesthesia. Participants are randomly assigned to either an intervention group, which watches a digital storytelling-based animation before the procedure, or a control group receiving standard preoperative care. Anxiety is assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and Facial Image Scale (FIS). Physiological parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, are also evaluated. The study aims to determine whether the animation-based intervention reduces preoperative anxiety and physiological stress responses in children.
Detailed description
This study is a randomized controlled trial conducted with children aged 5-12 years scheduled to undergo dental treatment under general anesthesia. The study investigates whether a digital storytelling-based animation presented during the preoperative period can reduce children's anxiety and physiological stress responses.
Participants are randomly allocated to an intervention group or a control group. Children in the intervention group watch a digital storytelling-based animation before the procedure, whereas children in the control group receive standard preoperative care without the animation intervention.
Children's anxiety is evaluated using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) and the Facial Image Scale (FIS) before and after the intervention. Physiological parameters, including heart rate, systolic and diastolic blood pressure, respiratory rate, and oxygen saturation, are assessed at predefined time points during the perioperative period.
The primary objective is to evaluate the effect of the digital storytelling-based animation on preoperative anxiety. The secondary objective is to evaluate its effect on physiological parameters associated with the stress response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Storytelling-Based Animation Group | Experimental | Behavioral: Digital Storytelling-Based AnimationChildren assigned to this group received a digital storytelling-based animation intervention during the preoperative period before general anesthesia. The animation was administered before intravenous access and was designed to familiarize children with the perioperative process and reduce preoperative anxiety. In addition to the animation intervention, children received standard preoperative care. |
| Control Group | No intervention | –Children assigned to the control group received standard preoperative care without the digital storytelling-based animation intervention. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5-12 years. Children scheduled to undergo dental treatment under general anesthesia. Children whose parent or legal guardian provided written informed consent.
Key exclusion criteria (2 listed)
- Children with a previous experience of general anesthesia. Children with chronic diseases. Children with cognitive, developmental, or communication impairments that could prevent understanding the digital animation or completing the anxiety assessments.
- Children whose parent or legal guardian did not provide informed consent.
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 |
|---|---|---|
| Digital Storytelling-Based AnimationChildren in the experimental group watched a digital storytelling-based animation during the preoperative period before intravenous access. The animation was designed to familiarize children with the perioperative process in an age-appropriate and engaging manner and to reduce preoperative anxiety. | Behavioural | Digital Storytelling-Based Animation Group |
Primary outcome
Change in Preoperative Anxiety Measured by the Modified Child Dental Anxiety Scale-Faces (MCDAS-F)
Time frame: Immediately before and immediately after the intervention on the day of surgery
Children's preoperative anxiety was assessed using the Modified Child Dental Anxiety Scale-Faces (MCDAS-F). The scale consists of 8 items, each scored from 1 to 5, resulting in a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. MCDAS-F scores were assessed before and after the digital storytelling-based animation intervention in the experimental group and at corresponding time points in the control group.
5 secondary outcomes
Change in Preoperative Anxiety Measured by the Facial Image Scale (FIS)
Time frame: Immediately before and immediately after the intervention on the day of surgery
Change in Heart Rate
Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Respiratory Rate
Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
Change in Blood Pressure
Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively
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 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
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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.
Serpil Boran, PhD principal investigator
Recep Tayyip Erdogan 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 Digital Storytelling-Based Animation in people with Preoperative Anxiety and Dental Anxiety, run by Recep Tayyip Erdogan 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 1 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 17 Sep 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?
Change in Preoperative Anxiety Measured by the Modified Child Dental Anxiety Scale-Faces (MCDAS-F) (time frame: Immediately before and immediately after the intervention on the day of surgery). 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 17 Sep 2026.