Kaleidoscope and Helicone for Pain and Anxiety in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Pain Management Procedural Pain Children Pediatric Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Kaleidoscope Group

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.

Group Type EXPERIMENTAL

Kaleidoscope

Intervention Type 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 Group

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.

Group Type EXPERIMENTAL

Helicone

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes