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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07068672
Acronym
KHALPAIN
Enrollment
210
Registered
2025-07-16
Start date
2025-04-01
Completion date
2025-05-31
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Procedural Pain, Children, Pediatric Nursing

Keywords

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

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.

Interventions

BEHAVIORALKaleidoscope

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.

BEHAVIORALHelicone

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.

Sponsors

AYLİN ARIKAN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain level measured using Wong-Baker FACES Pain ScaleTwo minutes before the procedure, during needle insertion, and two minutes after the procedurePain 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.
Anxiety level measured using Children's Anxiety Meter - State (CAM-S)Two minutes before the procedure, during needle insertion, and two minutes after the procedureAnxiety 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026