Kaleidoscope and Helicone for Pain and Anxiety in Children

AYLİN ARIKAN210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Pain Management Procedural Pain

Interventions

KaleidoscopeBEHAVIORAL

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.

HeliconeBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children aged between 6 and 12 years * Requiring venipuncture for clinical purposes * Able to verbally communicate pain and anxiety * Accompanied by a parent or legal guardian who provides written informed consent * Child provides verbal assent to participate Exclusion Criteria: * Children with cognitive or neurological disorders affecting pain or anxiety perception * Use of any analgesics, anxiolytics, or sedatives within 6 hours prior to the procedure * Visual or hearing impairments that interfere with the use of kaleidoscope or helicone * Previous experience with similar distraction tools * Presence of any skin condition preventing pain scale assessment

Outcomes

Primary Outcomes

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.