NCT Number: NCT07513272
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.
Trial opening soon.
Get Notified7 year–12 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
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.
Time frame: Immediately before, during, and immediately after 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 will be assessed using the Wong-Baker Faces Pain Rating Scale (WBS) before, during, and after venipuncture.
Contact information is provided by the study sponsor or research team.
aylin arıkan, phd
CONTACT
zeynep yurdakul, phd
CONTACT
Ankara University
Other
THE EFFECT OF TWO DIFFERENT BALLS USED DURING VENIPUNCTURE IN CHILDREN ON PAIN AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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