Effect of Buzzy®, Cognitive Behavioral Intervention, and Kaleidoscope During SC Injection in Children With Cancer

Summary

Subcutaneous injections are commonly used in pediatric oncology care and may cause pain, fear, and anxiety in children. Repeated exposure to needle-related procedures may increase procedural distress and affect children's cooperation and coping during treatment. Therefore, simple, safe, and feasible non-pharmacological interventions are needed to improve children's comfort during routine procedures.

This randomized parallel trial was designed to compare three clinically feasible non-pharmacological approaches with different mechanisms during subcutaneous injections in children with cancer. Buzzy® provides cold and vibration as a sensory-based method, the cognitive behavioral intervention package supports preparation and coping, and the kaleidoscope provides visual distraction. By comparing these approaches within the same procedural context, the study aimed to provide practical evidence for pediatric oncology nurses when selecting interventions to reduce procedural distress.

All procedures were conducted in the routine clinical procedure area of a pediatric oncology clinic. The same subcutaneous injection procedure was used for all participants, and standardized assessment time points were applied before and immediately after the procedure.

Conditions

• Pediatric Cancer
• Procedural Pain
• Procedural Fear in Children
• Procedural Anxiety

Interventions

BEHAVIORAL

Cognitive Behavioral Intervention Package Group

The Cognitive Behavioral Intervention Package was delivered by the researcher before, during, and after the subcutaneous injection. Before the procedure, the child received brief age-appropriate preparation, selected a preferred distraction or coping strategy, and the parent was guided on how to support the child. During the injection, the researcher provided standardized verbal coaching, encouragement, and coping support, while the parent provided physical and verbal comfort. The child used the selected coping strategy throughout the injection. After completion of the outcome assessments, brief positive reinforcement was provided. The intervention was implemented using a structured checklist to support standardization.

DEVICE

Buzzy® Group

The Buzzy® device was used as a cold and vibration intervention during subcutaneous injection. The device was placed at the injection site 60 seconds before needle insertion, and cold and vibration were initiated. Immediately before needle insertion, the device was repositioned approximately 3 cm proximal to the injection site. It remained in place throughout the injection and was removed immediately after the procedure was completed. No additional distraction or cognitive behavioral coaching was provided beyond standard procedural explanations.

DEVICE

Kaleidoscope Group

The kaleidoscope was used as a visual distraction intervention during subcutaneous injection. The child was shown the kaleidoscope shortly before the procedure and was allowed a brief familiarization period. The kaleidoscope was introduced approximately 1 minute before needle insertion, and the child continued to look through it throughout the injection. The intervention ended when the injection was completed. No additional cognitive behavioral coaching or cold/vibration intervention was provided beyond standard procedural explanations.

Sponsors & Collaborators

• Kocaeli University

  lead OTHER

Principal Investigators

• Birgül Erdoğan, PhD, RN · Kocaeli University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2025-02-12

Completion

2025-09-24

Countries

• Turkey (Türkiye)

Study Locations