Clinical trial · Interventional
The Effects of Nonpharmacological Methods Used in Subcutaneous Application on Pain, Anxiety, and Fear Levels in Children
The Effects of Three Different Nonpharmacological Methods Used in Subcutaneous Application on Pain, Anxiety, and Fear Levels in Children With Oncology Diagnosis
- 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)
Childhood cancers are increasing globally and require long-term invasive treatments, particularly subcutaneous applications that often cause pain, swelling, and anxiety. Effective pain and anxiety management is essential, as early traumatic experiences may shape children's future pain responses. Nonpharmacological methods-classified as physical, cognitive, and behavioral-are widely used alongside pharmacological strategies due to their safety, cost-effectiveness, and ease of application. Although studies show these methods reduce pain and anxiety, there is still a need for high-quality research comparing multiple approaches across different age groups and procedures. This study aims to evaluate and compare the effectiveness of combined physical, cognitive, and behavioral interventions in managing pain, anxiety, and fear among children with oncological diagnoses undergoing invasive procedures.
Conditions
Conditions (1)
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 Oncology | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buzzy | Behavioral | — | UNRESOLVED |
| Cognitive behavioral intervention | Behavioral | — | UNRESOLVED |
| Kaleidoscope | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Kaleidoscope
- description
- After subcutaneous administration, children will rate their pain levels during and after the procedure with the Wong Baker Scale, their anxiety levels with the Children's State Anxiety Scale (CSA), and their fear levels with the Children's Fear Scale (CFS). A parent present with the child will observe the child's behavioral state during the procedure and will rate the child's fear level during and after the procedure with the CFS and their anxiety level with the CSA.
- interventionNames
- Behavioral: Kaleidoscope
- type
- EXPERIMENTAL
- label
- Buzzy
- description
- For children in this group, a Buzzy device will be placed on the treatment area 60 seconds before the subcutaneous application begins, and cold and vibration will be applied. At the end of this period, the nurse will slide the Buzzy device approximately 3 cm above the treatment area, and the procedure will be performed. The Buzzy device will continue throughout the procedure, and once the procedure is complete, the Buzzy device will be removed. After subcutaneous administration, children will rate their pain levels during and after the procedure with the Wong Baker Scale, their anxiety levels with the Children's State Anxiety Scale (CSA), and their fear levels with the Children's Fear Scale (CFS). A parent present with the child will observe the child's behavioral state during the procedure and will rate the child's fear level during and after the procedure with the CFS and their anxiety level with the CSA.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 14 Months
Show eligibility criteria text
Inclusion Criteria: * Children aged 6-14 years, * Have an oncological diagnosis, * Have received at least one chemotherapy treatment before, * And whose parents are willing to participate in the study will be included in the study. Exclusion Criteria: * Children with any visual, auditory, verbal, or cognitive impairment, * Those in the terminal stages of their illness, * Those with a history of sedative, analgesic, or narcotic use within 24 hours of admission, * Those with a febrile illness or history of infection at the time of admission, * Those with a score of 2 or higher on the Wong-Baker Pain Scale independent of the procedure (during the pre-procedure assessment), * Those who do not complete the study will not be included in the study.
References
Publications (0)
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