Comparison of the Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years: A Randomized Experimental Study

Research Hypotheses:

H1= There is a difference in the mean WB-FACES score during the procedure between the game group (GG) and the cartoon group (CG).

H2= There is a difference in the mean CFS score during the procedure between the GG and CG groups.

Design and Settings: This parallel-group randomized trial will be conducted at the invasive procedure room of the pediatrics department of a university hospital. For this experimental research, 64 children aged 6-9 years will be assigned to two groups (Game Group=GG; n = 32 and Cartoon Group=CG; n = 32) using block randomization.

Sample Size: The trial sample was calculated based on the study findings of "Ugucu, G., Uysal, D. A., Polat, O. G., Artuvan, Z., Kulcu, D. P., Aksu, D., ... & Temel, G. O. (2022). Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: a randomized experimental study. Journal of Pediatric Nursing, 65, e107-e114.". A priori power analysis was performed based on the effect size (d = 0.885, large effect) of the difference in pain scores between the groups (during the procedure). Using G*Power 3.1.9.7, the minimum sample size was calculated as 56 children, with 28 children per group, for a two-tailed hypothesis, an effect size of d = 0.885, an allocation ratio of n1/n2=1, type I error of 0.05, and a power of 90%. Considering that there may be drop-outs during the process, the number of groups was increased by 20%. The sample size of this study was determined as 64 children (32 children in each intervention group).