An interventional study of Soft ball and spiky ball in Venipuncture-related Pain and Anxiety, sponsored by Ankara University. Not yet recruiting. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Ankara University · Not applicable, Interventional, and Prevention
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 144 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Other: Soft 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 undergo standard venipuncture care without the use of any ball or additional distraction intervention.
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.
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
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared to protect participant privacy and confidentiality.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ankara University