Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir, 34480, Turkey (Türkiye)
NCT Number: NCT07127432
This randomized controlled trial aims to evaluate the effect of using the "Storytelling Caterpillar" toy on pain, anxiety, and parental satisfaction during blood draw procedures in children aged 3 to 6 years. The Storytelling Caterpillar is a colorful, interactive toy that combines visual, auditory, and tactile stimuli to engage children's attention through storytelling and music. The study will compare an intervention group, where the toy is used during the blood draw, with a control group receiving standard care without the toy. Outcomes will include pain levels assessed using the FLACC scale, anxiety levels evaluated with the Visual Analog Scale for Anxiety (VAS-A), and parental satisfaction measured using a VAS satisfaction score. The results are expected to provide evidence on the effectiveness of storytelling-based distraction in improving the procedural experience for children and their parents.
Looking for future studies?
Notify Me3 year–6 year
All sexes
Interventional
Not applicable
Istanbul, Başakşehir, 34480, Turkey (Türkiye)
Fear of medical procedures can reduce children's participation in healthcare, hinder access to medical services, and negatively impact the treatment process. Needle-related interventions such as blood draws, injections, and intravenous catheter insertions are often perceived by children as painful, frightening, and potentially traumatic. These experiences are more common in children with chronic illnesses, where the anticipation of pain often leads to heightened anxiety. Pediatric nurses, who frequently perform these invasive procedures, play a critical role in minimizing pain and anxiety during medical care. In addition to pharmacological methods, non-pharmacological approaches are commonly used due to their ease of application and absence of side effects. Among these, distraction techniques are widely preferred. These methods aim to divert the child's attention away from the procedure to a more engaging stimulus, thereby reducing pain, fear, and anxiety. Such interventions not only alleviate acute symptoms but also enhance treatment compliance and overall outcomes. Furthermore, distraction strategies can help reduce parental anxiety.
It is recommended that distraction tools used in pediatric settings incorporate both visual and auditory stimuli. One such method is storytelling with visual materials. Storytelling involves conveying narratives through words, sounds, and images, helping children process experiences and manage emotional responses by transforming events into coherent narratives. As a non-invasive, cost-effective, and easy-to-use technique, storytelling can reduce pain and anxiety in hospitalized children. Stories also serve as models for teaching values and coping strategies, providing insight at both conscious and subconscious levels. By focusing the child's attention on the story rather than the procedure, storytelling shifts perception away from the painful stimulus. Immersion in storytelling may also stimulate physiological responses that contribute to reduced pain and fear. Previous studies have shown that storytelling in pediatric populations can lead to lower anxiety and pain levels during medical procedures.
In light of this, the present study aimed to evaluate the effectiveness of a developmentally appropriate distraction tool-the Storytelling Caterpillar-in reducing pain and anxiety during blood draw procedures in children aged 3 to 6 years. This colorful, music-playing, interactive toy is designed to tell stories while stimulating the visual, auditory, and tactile senses, making it particularly engaging for this age group. It was expected that the use of the Storytelling Caterpillar would not only help reduce children's procedural anxiety and pain but also support pediatric nurses by facilitating the procedure and increasing the child's cooperation. Additionally, improvements in parental satisfaction were anticipated as a result of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Storytelling Caterpillar is a plastic toy measuring 19.5 × 5.5 × 25.5 cm and is recommended for use in children aged 1-6 years. It is designed in the form of a storybook and includes interactive f
Time frame: Pain was measured once - immediately after the procedure (experienced pain).
Pain was assessed using the Wong-Baker FACES Pain Rating Scale, a validated self-report tool for children. The scale consisted of six illustrated faces ranging from a happy face (score of 0, indicating "no pain") to a crying face (score of 10, indicating "worst pain"). Children were asked to choose the face that best represented the pain they felt during the procedure.
Time frame: Fear was measured twice - immediately before the procedure (anticipated fear) and during the procedure (observed fear).
The child's fear level was assessed using the Children's Fear Scale, a 5-face pictorial scale scored from 0 ("no fear") to 4 ("maximum fear").
Time frame: Anxiety was measured twice - immediately before the procedure (anticipated anxiety) and immediately after the procedure (experienced anxiety).
The child's anxiety level was assessed using the Visual Analog Scale for Anxiety (VAS-A), a 10 cm horizontal line scored from 0 ("no anxiety") to 10 ("worst possible anxiety"), with each point represented by a corresponding facial expression. Parents were asked to rate the child's anxiety level on the scale.
Time frame: Satisfaction was measured once - immediately after the procedure.
Both the child and the parent rated their satisfaction with the Storytelling Caterpillar on a scale from 1 ("not satisfied at all") to 10 ("very satisfied").
Koç University
Other
The Effect of Storytelling Caterpillar Use on Pain, Anxiety, and Parental Satisfaction During Blood Draw in Children Aged 3 to 6 Years: A Randomized Controlled Trial
Acronym: SC-PAS
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.
Published trials that share one or more normalized conditions with this study.
NCT02207049
Children, Preschool, Energy Intake
Knoxville, Tennessee, United States
View Trial DetailsNCT05178290
Behavior, COVID-19 Testing
Phoenix, Arizona, United States
View Trial DetailsNCT06215183
Anxiety Disorders, Behavior
Istanbul, Pendik, Turkey (Türkiye)
View Trial DetailsNCT07565142
Anxiety Disorders, Complementary Therapies
Baltimore, Maryland, United States
View Trial Details