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Completed

NCT Number: NCT07667712

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

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.

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Key information

Conditions

Pediatric Cancer Neoplasms Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Anxiety Procedural Fear in Children Procedural Pain Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

About this study

This study was conducted as a randomized, parallel-group clinical trial in children with cancer undergoing routine subcutaneous injection. Participants were assigned to one of three intervention groups: Buzzy®, a cognitive-behavioral intervention package, or kaleidoscope distraction.

All interventions were delivered in the same clinical setting and within the same procedural context. Before the injection, baseline levels of procedural fear and state anxiety were assessed. The assigned intervention was then applied according to the group allocation during the subcutaneous injection procedure. Pain, fear, and state anxiety were evaluated immediately after the procedure using standardized pediatric assessment tools.

The trial was designed to compare three non-pharmacological strategies that are practical for use in pediatric oncology nursing care. The purpose was to determine whether sensory stimulation, cognitive-behavioral preparation and coping support, or visual distraction differed in their effects on procedural pain, fear, and anxiety during subcutaneous injection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 6 to 12 years
  • Diagnosis of cancer
  • Having received chemotherapy at least once
  • Willingness of both the child and parent to participate in the study

Exclusion criteria

  • Visual, auditory, verbal, or cognitive impairment preventing participation
  • Terminal stage of disease
  • Use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
  • Baseline pain score of 2 or higher on the Wong-Baker Faces Pain Rating Scale unrelated to the procedure
  • Inability to complete the injection in a single attempt
  • Withdrawal before completion of the study procedures

Treatment and study plan

Cognitive Behavioral Intervention Package Group

Behavioral

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.

Buzzy® Group

Device

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.

Kaleidoscope Group

Device

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.

Primary outcomes

  1. Post-Procedural Pain Intensity Assessed Using the Wong-Baker FACES Pain Rating Scale

    Time frame: Immediately after subcutaneous injection

    Post-procedural pain intensity will be assessed immediately after subcutaneous injection using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 5, with 0 indicating no pain and 5 indicating the worst pain. Higher scores indicate greater pain intensity.

Secondary outcomes

  1. Procedural Fear Assessed Using the Children's Fear Scale

    Time frame: Before and immediately after subcutaneous injection

    Procedural fear will be assessed before and immediately after subcutaneous injection using the Children's Fear Scale. This scale ranges from 0 to 4, with 0 indicating no fear and 4 indicating extreme fear. Higher scores indicate greater procedural fear.

  2. State Anxiety Assessed Using the Children's Anxiety Scale-State

    Time frame: Before and immediately after subcutaneous injection

    State anxiety related to subcutaneous injection will be assessed before and immediately after the procedure using the Children's Anxiety Scale-State. This scale ranges from 0 to 10, with 0 indicating no anxiety and 10 indicating the highest level of anxiety. Higher scores indicate greater state anxiety.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Buzzy®, a Cognitive-Behavioral Intervention Package, and a Kaleidoscope for Reducing Pain, Fear, and Anxiety During Subcutaneous Injections in Children With Cancer: A Three-Arm Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

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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