EFFECT OF BALLS ON PAIN AND ANXIETY DURING VENIPUNCTURE IN CHILDREN

N/ANot Yet RecruitingNCT07513272

Ankara University144 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

144

Conditions

Venipuncture-related Pain and Anxiety

Interventions

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.

spiky ballOTHER

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Anxiety Level During Venipuncture

Anxiety will be assessed using the Child Anxiety Scale-Situational before, during, and after venipuncture.

Time frame: Immediately before, during, and immediately after venipuncture

Pain Level During Venipuncture

Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBS) before, during, and after venipuncture.

Time frame: Immediately before, during, and immediately after venipuncture

Central Contacts

zeynep yurdakul, phd

CONTACT

05545640036 zeyneppyurdakull@gmail.com

aylin arıkan, phd

CONTACT

aylnarkn@hotmail.com

Data from ClinicalTrials.gov

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