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NCT Number: NCT07825493

Digital Storytelling-Based Animation for Preoperative Anxiety in Children

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.

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Key information

Conditions

Preoperative Anxiety Dental Anxiety

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan University Faculty of Dentistry

Rize, Rize Province, 53100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children aged 5-12 years. Children scheduled to undergo dental treatment under general anesthesia. Children whose parent or legal guardian provided written informed consent.

Exclusion criteria

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.

Treatment and study plan

Digital Storytelling-Based Animation

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Change in Heart Rate

    Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively

    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.

  3. Change in Peripheral Oxygen Saturation (SpO₂)

    Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively

    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.

  4. Change in Respiratory Rate

    Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively

    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.

  5. Change in Blood Pressure

    Time frame: Before the intervention, immediately after the intervention, before general anesthesia induction, and 2 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Effect of Digital Storytelling-Based Animation on Preoperative Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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