The Effect of Therapeutic Play Applied With Amigurumi Toys

NCT06746506 | Completed

• 1 other identifier: Gamzegulaltay
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effect of therapeutic play with amigurumi toys on pain and fear during blood collection in children aged 4 to 6 years who applied to the pediatric emergency department. The project is a randomized controlled trial. The study covers children aged 4-6 years who came to the blood collection unit of the pediatric emergency department of Recep Tayyip Erdoğan University Education and Research Hospital between January and June 2025. The research sample will consist of children who applied to the unit on the specified dates, met the research criteria, and volunteered to participate in the study. The "Survey Form", "Wong-Baker Facial Expression Assessment Scale" and "Child Fear Scale" will be used to collect data.

Conditions

Bloodletting

Keywords

bloodletting; fear; pain; children; amigurumi toy

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Facial Expression Evaluation Scale

  The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.

  6 months

• Child Fear Scale

  The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).

  6 months

Study Arms (2)

Amigurumi toy, pain and fear

EXPERIMENTAL

Behavioral: Amigurumi toy

control not pain and fear

NO INTERVENTION

Interventions

Amigurumi toy BEHAVIORAL

A toy prepared using anti-allergic yarn to suit children's developmental stages.

Amigurumi toy, pain and fear

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-6,
• Those who applied to the hospital as outpatients due to an acute illness,
• Those who were rated as yellow triage in the 3-level (red-yellow-green) triage system,
• Those whose mother or father was with the child during the procedure,
• Those whose blood was drawn with a single procedure,
• Those whose health status was stable will be included in the study.

You may not qualify if:

• \- Children who have a history of sedative, analgesic or narcotic substance use within 24 hours before application,
• Children with a fever higher than 38 °C,
• Children with visual, hearing, language development, mental and neurological disorders,
• Children with a chronic or life-threatening disease,
• Children who refuse to participate in the study,
• Children who are treated in the red or green zone according to the triage system (red = critical emergency, requiring immediate action; yellow = unstable condition, requiring intervention within 60 minutes; and green = stable condition, intervention should be performed within 2 hours) will not be included in the study.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Güneysu, 53350, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 1, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)