Purpose: This study evaluated the effects of a Cognitive-Behavioral Intervention Package (CBIP) on pain, fear, and anxiety in children undergoing port catheter needle insertion in pediatric oncology.
Design and methods: In a parallel-group randomized controlled trial conducted at a university hospital in Turkey (December 2024-August 2025), 48 children aged 6-12 years were stratified by age, sex, and prior fear of port access and randomized to CBIP (n = 24) or control (n = 24). CBIP comprised preparation and information, pre-procedural distraction, verbal reassurance, parental education and participation, distraction during the procedure, and positive reinforcement. Outcomes were assessed pre/post using the Wong-Baker FACES Pain Rating Scale (WB-FACES), Children's Fear Scale (CFS), and Children's Anxiety Scale-State (CASS). Between-group differences, effect sizes, and 95% confidence intervals (CIs) were calculated.
Results: Mean age was 9.31 years (SD = 2.03; range = 6-12). Groups were comparable at baseline (p > 0.05). Post-procedure, CBIP showed lower pain (0.58 ± 0.77 vs. 2.29 ± 1.80), fear (0.45 ± 0.65 vs. 2.08 ± 1.76), and anxiety (0.37 ± 0.82 vs. 2.62 ± 2.16) than control (all p < 0.001). Mean differences (CBIP-Control) were - 1.71 (95% CI: -2.51 to -0.91) for pain, -1.63 (-2.40 to -0.86) for fear, and - 2.25 (-3.20 to -1.30) for anxiety, with large effect sizes (d = 1.23-1.40).
Conclusions: CBIP reduced pain, fear, and anxiety during port needle insertion and is a feasible, nurse-deliverable approach for routine pediatric oncology care.
Keywords: Anxiety; Fear; Pain; Pediatric oncology; Port catheter.
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