The Effect of Using Virtual Reality on Pain, Fear and Anxiety by School-Age Children During Venipuncture: A Randomized Controlled Study

This randomized controlled clinical trial (RCT) was conducted between September 2022 and May 2023 with two parallel groups in the pediatric inpatient service of a private hospital in western Turkey.

In order to determine the number of patients constituting the research sample, a similar study in the relevant literature was taken as an example and the power analysis G*Power 3.1 software was used. In this study, in order to reach a power level of 95% at a 0.5 effect size and 5% error level, the sample size was calculated as 56, with 28 participants in each group. Considering the high power of the test and the losses in the study, a total of 60 people were reached, 30 in each group.The study sample consisted of children aged 6-12 years with stable hemodynamics who were undergoing venipuncture, had sufficient cognitive and communication abilities to rate their pain, fear, and anxiety levels, and were willing to participate. This group was selected because children of that age are the most cooperative. All participating children gave verbal consent to participate, and their families provided written consent. Children with unstable conditions and vital signs, intubated, had visual problems or did not want to participate in the study were excluded.

Children meeting the sampling criteria were randomly allocated to one of the two groups: the VR group and the control group. First, group numbers were written on uniform pieces of paper as 30 VR 30 control, and the papers were placed into closed box. Participants were asked to pick one card among the 60. They were assigned to the group according to their card. Thus, each group had 30 children in each group and 60 children in the study.

The research's outcomes were pain levels assessed with the Wong-Baker Faces Pain Rating Scale (WBS), fear levels assessed with the Children's Fear Scale (CFS), anxiety levels assessed with the State-Trait Anxiety Inventory for children (STAI-CH). WBS and CFS were scored separately by the researcher, the child and the parent, and STAI-CH was scored by the child alone within five minutes before and immediately after the procedure. All ratings were done blindly to ensure that the observers did not influence each other's scores.

The researchers created the child information form and included nine questions about the children's age, sex, parents' age, education level, economic level, and type of family.