Kaleidoscope and Helicone for Pain and Anxiety in Children

NCT07068672 | Completed

• 2 other identifiers: AESH-B-2025-0123AEŞH-BADEK-2025-0123
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kaleidoscope; Helicone; Pediatric Pain Management; School-Age Children; Venipuncture

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Two minutes before the procedure, during needle insertion, and two minutes after the procedure

Study Arms (3)

Kaleidoscope Group

EXPERIMENTAL

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

Helicone Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Children in this group received standard care during venipuncture without any distraction tools. No visual or tactile distraction was provided.

Interventions

Kaleidoscope BEHAVIORAL

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.

Kaleidoscope Group

Helicone BEHAVIORAL

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.

Helicone Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AYLİN ARIKAN: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Procedural

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Philosophy in Pediatric Nursing

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: April 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)