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Not yet recruiting NCT07513272

EFFECT OF BALLS ON PAIN AND ANXIETY DURING VENIPUNCTURE IN CHILDREN

No phase Interventional Venipuncture-related Pain and Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soft ball, spiky ball.
Who it may be relevant to
Registry conditions: Venipuncture-related Pain and Anxiety. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Anxiety Level During Venipuncture [Time frame: Immediately before, during, and immediately after venipuncture]
  • Pain Level During Venipuncture [Time frame: Immediately before, during, and immediately after venipuncture]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Hjelmgren H, Ygge BM, Nordlund B, Andersson N. Nurses' experiences of blood sample collection from children: a qualitative study from Swedish paediatric hospital care. BMC Nurs. 2022 Mar 15;21(1):62. doi: 10.1186/s12912-022-00840-2. PMID 35292007

Identifiers

NCT: NCT07513272 · PAIN AND ANXIETY VENIPUNCTURE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗