An interventional study of Kaleidoscope and Helicone in Pain Management, Procedural Pain and Children, sponsored by AYLİN ARIKAN. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by AYLİN ARIKAN · Not applicable, Interventional, and Treatment
This randomized controlled trial aimed to evaluate the effects of kaleidoscope and helicone distraction tools on pain and anxiety levels during venipuncture in school-age children. The study was conducted at Ankara Etlik City Hospital Pediatric Emergency Department between April and May 2025. A total of 210 children aged 6 to 12 years who were undergoing venous blood sampling for the first time were randomly assigned to one of three groups: Kaleidoscope, Helicone, or Control (standard care). The Kaleidoscope group used a passive distraction tool featuring dynamic visual patterns; the Helicone group used an active distraction tool that involves hand manipulation of a rotating toy. Pain levels were measured using the Wong-Baker FACES Pain Rating Scale, and anxiety levels were assessed using the Children's Anxiety Meter-State (CAM-S). Measurements were taken before, during, and after the procedure. This study seeks to determine the comparative effectiveness of active versus passive distraction techniques in pediatric procedural pain and anxiety management. All interventions were non-pharmacological, non-invasive, and conducted in a safe clinical setting with informed consent obtained from both children and their guardians.
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Exclusion Criteria:
Children in this group were provided with a handheld kaleidoscope starting 2 minutes before and during venipuncture. The visual distraction created by the kaleidoscope's changing colorful patterns aimed to reduce pain and anxiety. The child focused on the visual display throughout the procedure.
Behavioral: Kaleidoscope
Children in this group used a helicone toy starting 2 minutes before and during venipuncture. The toy, which changes shape with hand manipulation, provided active distraction to reduce pain and anxiety by engaging both visual and tactile senses.
Behavioral: Helicone
Children in this group received standard care during venipuncture without any distraction tools. No visual or tactile distraction was provided.
A handheld kaleidoscope was used as a passive distraction tool during venipuncture. The device was introduced to the child 2 minutes before the procedure and remained in view during blood collection. It provided dynamic, colorful visual stimuli to help reduce pain and anxiety.
A helicone toy was used as an active distraction tool. Children held and rotated the device beginning 2 minutes before and during venipuncture. The interactive movement and shape-shifting design engaged the child's attention to reduce procedural pain and anxiety.
Pain level measured using Wong-Baker FACES Pain Scale
Pain was assessed by the child using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where higher scores indicate more severe pain. Evaluations were conducted at three time points: before the procedure, during needle insertion, and two minutes after.
Time frame: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Anxiety level measured using Children's Anxiety Meter - State (CAM-S)
Anxiety was evaluated using the Children's Anxiety Meter - State (CAM-S) tool. The scale ranges from 0 (no anxiety) to 10 (extreme anxiety). Assessments were completed by the child with assistance from the researcher at three time points: before, during, and after the venipuncture.
Time frame: Two minutes before the procedure, during needle insertion, and two minutes after the procedure
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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