NCT07068672

Kaleidoscope and Helicone for Pain and Anxiety in Children

Effect of Kaleidoscope and Helicone Use on Pain and Anxiety During Venipuncture in School-Age Children: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: AYLİN ARIKAN · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain Management
• Procedural Pain
• Children
• Pediatric Nursing

Interventions

Type	Name	Description
BEHAVIORAL	Kaleidoscope	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.
BEHAVIORAL	Helicone	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2025-07-16
• Last updated: 2025-07-18

Locations

1 site across 1 country: Turkey (Türkiye)