Clinical trial · Interventional
Effect of Buzzy®, Cognitive Behavioral Intervention, and Kaleidoscope During SC Injection in Children With Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Procedural Anxiety | — | UNRESOLVED | — |
| Procedural Fear in Children | — | UNRESOLVED | — |
| Procedural Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buzzy® Group | Device | — | UNRESOLVED |
| Cognitive Behavioral Intervention Package Group | Behavioral | — | UNRESOLVED |
| Kaleidoscope Group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive-Behavioral Intervention Package Group
- description
- Children assigned to this group received the cognitive-behavioral intervention package during the subcutaneous injection procedure.
- interventionNames
- Behavioral: Cognitive Behavioral Intervention Package Group
- type
- ACTIVE_COMPARATOR
- label
- Buzzy® Group
- description
- Children assigned to this group received the Buzzy® intervention during the subcutaneous injection procedure.
- interventionNames
- Device: Buzzy® Group
- type
- ACTIVE_COMPARATOR
- label
- Kaleidoscope Group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDErdogan 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
- BACKGROUNDBekar 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
- BACKGROUNDErdogan 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
- BACKGROUNDde 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
- BACKGROUNDMcNeil 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
- BACKGROUNDLoeffen 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.