Storytelling Caterpillar - Pain, Anxiety, and Satisfaction

NCT07127432 | Completed

• 1 other identifier: KOCUNIV
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Children, Preschool; Pain and Anxiety

Keywords

distraction; satisfaction; storytelling; distraction techniques

Outcome Measures

Primary Outcomes (3)

• 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.

  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").

  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.

  Anxiety was measured twice - immediately before the procedure (anticipated anxiety) and immediately after the procedure (experienced anxiety).

Secondary Outcomes (1)

• Satisfaction Level

  Satisfaction was measured once - immediately after the procedure.

Study Arms (2)

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.

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.

Interventions

The Storytelling Caterpillar DEVICE

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

Intervention-Storytelling Caterpillar

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• being between 3 and 6 years of age,
• having a parent who voluntarily agreed to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead
• Çam Sakura Şehir Hastanesi: collaborator

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied due to the nature of the intervention; both participants and outcome assessors were aware of group assignments
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 20, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)