Effects of Pop-it Game and Stress Ball Use on Pain and Anxiety During Blood Collection in Children Aged 3-6 Years

NCT07842263 | Completed

• 2 other identifiers: TUTF-GOBAEK 2024/4582025/40
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Blood collection can cause pain and anxiety in children. This randomized controlled study investigated whether using a pop-it game or a stress ball during blood collection could reduce pain and anxiety in children aged 3-6 years. The study included 78 children who were assigned to a pop-it game group, a stress ball group, or a control group. Pain and anxiety levels were assessed during the blood collection procedure.

Conditions

Pain; Anxiety; Blood Collection

Keywords

Pain; Anxiety; pop-it toys; stress balls

Outcome Measures

Primary Outcomes (2)

• Child-reported pain experienced during the blood collection procedure assessed using the Wong-Baker FACES Pain Rating Scale

  Child-reported pain experienced during the blood collection procedure was assessed using the Wong-Baker FACES Pain Rating Scale immediately after completion of the blood collection procedure

  Immediately after completion of the blood collection procedure

• Child-reported post-procedural pain assessed using the Wong-Baker FACES Pain Rating Scale

  Child-reported post-procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale 1 minute after completion of the blood collection procedure.

  1 minute after completion of the blood collection procedure

Secondary Outcomes (3)

• Anxiety assessed using the Children's Emotional Expression Assessment Scale by parents and researchers

  1 minute before the blood collection procedure; immediately after the procedure for observations made during the procedure; and 1 minute after the procedure

• Crying duration before, during and after the blood collection procedure

  Perioperative/Periprocedural

• Duration of the blood collection procedure

  From initiation to completion of the blood collection procedure

Study Arms (3)

Pop-it Game Group

EXPERIMENTAL

Children in this group played with a pop-it toy during the blood collection procedure

Behavioral: Pop-it Game

Stress Ball Group

EXPERIMENTAL

Children in this group squeezed and released a stress ball during the blood collection procedure

Behavioral: Stress Ball

Control Group

NO INTERVENTION

Children in this group underwent the routine blood collection procedure without the use of a pop-it game or stress ball.

Interventions

Pop-it Game BEHAVIORAL

Children in the Pop-it Game Group played with a pop-it toy during the blood collection procedure

Pop-it Game Group

Stress Ball BEHAVIORAL

Children in the Stress Ball Group squeezed and released a stress ball during the blood collection procedure

Stress Ball Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 6 years.
• Accompanied by a parent.
• Absence of any auditory, mental, or neurological disability
• Being communicative and open to interaction.
• Not having received any analgesic, antipyretic, anti-inflammatory, sedative, or anxiolytic medication within the previous 6 hours.
• Absence of acute pain prior to the procedure.
• Phlebotomy performed by the same nurse.
• No history of regular invasive procedures (i.e., no chronic disease requiring routine blood monitoring, such as cancer or diabetes).
• Willingness of both the child and parent to participate in the study.

You may not qualify if:

• inability to perform the phlebotomy procedure on the first attempt.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Bensu KENAR, MSN

  Trakya University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Melahat Akgün Kostak, PhD

  Faculty of Health Sciences, Trakya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 25, 2026
• Study Start: June 20, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)