EFFECT OF BALLS ON PAIN AND ANXIETY DURING VENIPUNCTURE IN CHILDREN

April 2, 2026 updated by: Zeynep Yurdakul, Ankara University

THE EFFECT OF TWO DIFFERENT BALLS USED DURING VENIPUNCTURE IN CHILDREN ON PAIN AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY

The goal of this clinical trial is to evaluate whether using two different types of balls can reduce pain and anxiety during venipuncture in school-aged children (7-12 years) in a pediatric emergency setting. The main questions it aims to answer are:

Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce perceived pain compared to a control group? Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce situational anxiety compared to a control group?

Researchers will compare the soft ball, textured ball, and control groups to see if the type of ball affects children's pain and anxiety levels.

Participants will:

Complete a demographic and clinical information form. Use Wong-Baker Faces Pain Rating Scale (WBS) and Child Anxiety Scale-State (ÇAS-D) to report pain and anxiety before, during, and after venipuncture.

Squeeze either a soft or textured ball during venipuncture (for experimental groups) while control group children receive standard care without distraction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Children aged 7-12 years. At least one prior experience of blood draw within the past year. Able to communicate in Turkish. Written informed consent obtained from both child and parents. No physical, auditory, intellectual, or neurological disabilities. No dermatological conditions affecting hand integrity. No analgesic, antipyretic, or anti-inflammatory drug use within the last 12 hours.

No acute pain reported before the procedure. No chronic illness causing regular invasive procedures or chronic pain.

Exclusion Criteria:

Inability to complete the first blood draw. Holding another object during the procedure. Withdrawal from the study at any point. Not meeting any of the inclusion criteria listed above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: soft ball
Participants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation.
Other: Soft ball
Participants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation. The ball is easily compressible, returns to its original shape, and is safe for repeated use.
Experimental: spiky ball
Participants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction.
Other: spiky ball
Participants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction. The ball has small rounded protrusions, offers resistance when squeezed, and is safe for repeated use.
No Intervention: Control
Participants will undergo standard venipuncture care without the use of any ball or additional distraction intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level During Venipuncture
Time Frame: Immediately before, during, and immediately after venipuncture
Anxiety will be assessed using the Child Anxiety Scale-Situational before, during, and after venipuncture.
Immediately before, during, and immediately after venipuncture
Pain Level During Venipuncture
Time Frame: Immediately before, during, and immediately after venipuncture
Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBS) before, during, and after venipuncture.
Immediately before, during, and immediately after venipuncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Hjelmgren, H., Ygge, B. M., Nordlund, B., & Andersson, N. (2022). Nurses' experiences of blood sample collection from children: A qualitative study from Swedish paediatric hospital care. BMC Nursing, 21(1), 62. https://doi.org/10.1186/s12912-022-00840-2

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAIN AND ANXIETY VENIPUNCTURE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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