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NCT Number: NCT07068672

Kaleidoscope and Helicone for Pain and Anxiety in Children

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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Key information

Conditions

Pain Management Agnosia Children Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Pediatric Nursing Perceptual Disorders Procedural Pain Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Etlik, 06270, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain level measured using Wong-Baker FACES Pain Scale

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

    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.

  2. Anxiety level measured using Children's Anxiety Meter - State (CAM-S)

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

    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.

Sponsors and collaborators

Lead sponsor

AYLİN ARIKAN

Other

Registry information

Official study title

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

Acronym: KHALPAIN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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