Kaleidoscope and Helicone for Pain and Anxiety in Children (KHALPAIN)

AYLİN ARIKAN

Status: Completed

Conditions: Pain Management; Children; Pediatric Nursing; Procedural Pain

Treatments: Behavioral: Kaleidoscope; Behavioral: Helicone

Study type: Interventional

Funder types: Other

Identifiers

NCT07068672

AESH-B-2025-0123

AEŞH-BADEK-2025-0123 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 3 patient groups

Kaleidoscope Group

Experimental group

Description:

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.

Treatment:

Behavioral: Kaleidoscope

Helicone Group

Experimental group

Description:

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.

Treatment:

Behavioral: Helicone

Control Group

No Intervention group

Description:

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