Storytelling Caterpillar - Pain, Anxiety, and Satisfaction

NCT ID: NCT07127432

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention-Storytelling Caterpillar

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.

Group Type: EXPERIMENTAL

The Storytelling Caterpillar

Intervention Type: 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

Standard care group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Storytelling Caterpillar

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 Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Çam Sakura Şehir Hastanesi

UNKNOWN

Sponsor Role: collaborator

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Eysan Hanzade Umac

Teaching Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOCUNIV

Identifier Type: -

Identifier Source: org_study_id