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

NCT07667712 | Completed

• 1 other identifier: SCINJ-PAIN-2025-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Immediately after subcutaneous injection

Secondary Outcomes (2)

• Procedural Fear Assessed Using the Children's Fear Scale

  Before and immediately after subcutaneous injection

• State Anxiety Assessed Using the Children's Anxiety Scale-State

  Before and immediately after subcutaneous injection

Study Arms (3)

Cognitive-Behavioral Intervention Package Group

ACTIVE COMPARATOR

Children assigned to this group received the cognitive-behavioral intervention package during the subcutaneous injection procedure.

Behavioral: Cognitive Behavioral Intervention Package Group

Buzzy® Group

ACTIVE COMPARATOR

Children assigned to this group received the Buzzy® intervention during the subcutaneous injection procedure.

Device: Buzzy® Group

Kaleidoscope Group

ACTIVE COMPARATOR

Children assigned to this group received kaleidoscope distraction during the subcutaneous injection procedure.

Device: Kaleidoscope Group

Interventions

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.

Cognitive-Behavioral Intervention Package Group

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.

Buzzy® Group

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.

Kaleidoscope Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, 41001, Turkey (Türkiye)

Location

Related Publications (6)

• Erdogan B, Ercelik ZE, Ozdemir AA. Effects of a cognitive-behavioral intervention package on pain, fear, and anxiety during port catheter needle insertion in children with cancer: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:98-106. doi: 10.1016/j.pedn.2026.02.017. Epub 2026 Feb 20.

  PMID: 41722145 BACKGROUND

• Bekar P, Erkul M, Efe E. The effect of using a kaleidoscope during central venous catheter dressing changes on pain and anxiety in children with cancer: A randomised controlled trial. Eur J Oncol Nurs. 2022 Apr;57:102114. doi: 10.1016/j.ejon.2022.102114. Epub 2022 Feb 25.

  PMID: 35248915 BACKGROUND

• Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.

  PMID: 33485746 BACKGROUND

• de la Maza V, Fuentes V, Cabrolier E, Fernandez MS, Saez S, Concha C, Nicklas C, Castro M, Torres JP. Efficacy, Safety, and Pain Level of Subcutaneous Catheter Use for Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer: A Randomized Pilot Study. J Pediatr Hematol Oncol Nurs. 2023 Sep-Oct;40(5):305-312. doi: 10.1177/27527530231190373. Epub 2023 Nov 3.

  PMID: 37920922 BACKGROUND

• McNeil MJ, Garcia Quintero X, Gonzalez M, Zheng Y, Ugaz Olivares C, Morales R, Boldrini E, Rebollo de Campos D, Ferreira D, Coopasamy K, Caneba J, Padernilla ML, Friedrichsdorf S, Baker JN, Friedrich P. Preventing and Treating Pain and Anxiety during Needle-Based Procedures in Children with Cancer in Low- and Middle-Income Countries. Cancers (Basel). 2024 Mar 1;16(5):1025. doi: 10.3390/cancers16051025.

  PMID: 38473383 BACKGROUND

• Loeffen EAH, Mulder RL, Font-Gonzalez A, Leroy PLJM, Dick BD, Taddio A, Ljungman G, Jibb LA, Tutelman PR, Liossi C, Twycross A, Positano K, Knops RR, Wijnen M, van de Wetering MD, Kremer LCM, Dupuis LL, Campbell F, Tissing WJE. Reducing pain and distress related to needle procedures in children with cancer: A clinical practice guideline. Eur J Cancer. 2020 May;131:53-67. doi: 10.1016/j.ejca.2020.02.039. Epub 2020 Apr 14.

  PMID: 32302949 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birgül Erdoğan, PhD, RN

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 25, 2026
• Study Start: December 1, 2024
• Primary Completion: February 12, 2025
• Study Completion: September 24, 2025
• Last Updated: June 25, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)