Children, PreschoolSC-PASNCT07127432
Storytelling Caterpillar - Pain, Anxiety, and Satisfaction
A study testing The Storytelling Caterpillar in people with Children, Preschool and Pain and Anxiety, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Children, Preschool, Pain and Anxiety
- What is being tested?
- The Storytelling Caterpillar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 20 Jun 2025
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between 3 and 6 years of age,
- having a parent who voluntarily agreed to participate in the study.
Who cannot join
- having a chronic illness requiring regular invasive procedures,
- having received analgesics within the past 2 hours,
- having experienced a seizure within the past 2 hours,
- using antiepileptic medication,
- having a body temperature above 37.5°C
- not having parental consent,
- being agitated at the time of the procedure,
- having any auditory or visual impairments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir, 34480
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Children, Preschool, Pain and Anxiety
- Being tested
- The Storytelling Caterpillar
- Keywords
- distraction, satisfaction, storytelling, distraction techniques
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Storytelling CaterpillarDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Storytelling Caterpillar | Experimental | Children in the intervention group were introduced to the 'Storytelling Caterpillar' toy, a colorful, interactive device with music and narrated stories designed to provide visual, auditory, and tactile stimulation. The toy was activated one minute before the blood draw procedure, with the child seated on the parent's lap. The storytelling continued throughout the procedure to divert the child's attention and reduce pain and anxiety. Receives: Device: The Storytelling Caterpillar |
| Standard care group | No intervention | Children in the control group received standard care during the blood draw procedure, which included parental presence and verbal reassurance provided by the nurse. No additional distraction or intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: Pain was measured once - immediately after the procedure (experienced pain).
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").
Measured: Fear was measured twice - immediately before the procedure (anticipated fear) and during the procedure (observed fear).
Anxiety Level
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.
Measured: Anxiety was measured twice - immediately before the procedure (anticipated anxiety) and immediately after the procedure (experienced anxiety).
Secondary outcomes (1)
Satisfaction Level
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").
Measured: Satisfaction was measured once - immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion20 Jun 2025
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 Children, PreschoolStudies 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
- Model description
- Parallel assignment randomized controlled trial in which participants are allocated to either an intervention group receiving the Storytelling Caterpillar distraction tool during venous blood draw or a control group receiving standard care. Outcomes are compared between groups.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127432
- Sponsor's protocol ID
- KOCUNIV
- Acronym
- SC-PAS
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 5 Sep 2025
- 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 the dataset contains identifiable health information of pediatric participants, and sharing is restricted to protect patient privacy in accordance with ethical and legal requirements.
Publications
Savas EH, Uysal G, Akdag MY, Sahin RS. The effect of storytelling caterpillar use on pain, fear, anxiety, and parental satisfaction during blood draw in children aged 3 to 6 years: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:222-230. doi: 10.1016/j.pedn.2026.02.020. Epub 2026 Feb 28.
PubMed 41762783
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07127432
- Acronym / sponsor ID
- SC-PAS / KOCUNIV
- Conditions
- Children, Preschool, Pain and Anxiety
- Keywords
- distraction, satisfaction, storytelling, distraction techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 17 Aug 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment randomized controlled trial in which participants are allocated to either an intervention group receiving the Storytelling Caterpillar distraction tool during venous blood draw or a control group receiving standard care. Outcomes are compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention-Storytelling Caterpillar | Experimental | Device: The Storytelling CaterpillarChildren in the intervention group were introduced to the 'Storytelling Caterpillar' toy, a colorful, interactive device with music and narrated stories designed to provide visual, auditory, and tactile stimulation. The toy was activated one minute before the blood draw procedure, with the child seated on the parent's lap. The storytelling continued throughout the procedure to divert the child's attention and reduce pain and anxiety. |
| Standard care group | No intervention | –Children in the control group received standard care during the blood draw procedure, which included parental presence and verbal reassurance provided by the nurse. No additional distraction or intervention was applied. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- being between 3 and 6 years of age,
- having a parent who voluntarily agreed to participate in the study.
Key exclusion criteria (8 listed)
- having a chronic illness requiring regular invasive procedures,
- having received analgesics within the past 2 hours,
- having experienced a seizure within the past 2 hours,
- using antiepileptic medication,
- having a body temperature above 37.5°C
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 |
|---|---|---|
| The Storytelling CaterpillarThe 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 | Device | Intervention-Storytelling Caterpillar |
Primary outcome
Pain intensity
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.
Fear
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").
Anxiety Level
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.
1 secondary outcome
Satisfaction Level
Time frame: Satisfaction was measured once - immediately after the procedure.
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 5 Sep 2025.
- Derived from this study: PubMed 41762783Savas EH, Uysal G, Akdag MY, Sahin RS. The effect of storytelling caterpillar use on pain, fear, anxiety, and parental satisfaction during blood draw in children aged 3 to 6 years: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:222-230. doi: 10.1016/j.pedn.2026.02.020. Epub 2026 Feb 28.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains identifiable health information of pediatric participants, and sharing is restricted to protect patient privacy in accordance with ethical and legal requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Storytelling Caterpillar in people with Children, Preschool and Pain and Anxiety, run by Koç 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 2 inclusion and 8 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 5 Sep 2025. 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?
Pain intensity (time frame: Pain was measured once - immediately after the procedure (experienced pain).). The study lists 3 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 NCT07127432, 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 5 Sep 2025.