NCT07667712Completed
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 · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 15 Jun 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- Kocaeli University
- Diseases
- Childhood cancers
- NCT number
- NCT07667712
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 1 Dec 2024 to the primary completion date, 12 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
Other illness
- Visual, auditory, verbal, or cognitive impairment preventing participation
- Terminal stage of disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kocaeli University Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.