Distraction-Based Interventions During Implanted Venous Port Catheter Needle Entry: Virtual Reality Application

This study is a randomized controlled experimental study planned to examine the effect of a virtual reality application during implanted venous port catheter needle insertion on patient satisfaction, comfort level, and time perception in cancer patients. Distraction-based interventions used in symptom management of cancer patients are simple, effective, and cost-effective. Distraction applications such as virtual reality glasses, listening to music, painting, and daydreaming aim to focus attention on another stimulus. Virtual reality application uses human-machine interfaces to focus the patient on a world other than their current environment with a three-dimensional virtual video, chaning teir perception of space and time. It has been shown that virtul reality applications reduce pain and anxiety, increase patient satisfaction, provide relief, and positively affect vital parameters during procedural procedures such as bone marrow aspiration, fine needle aspiration breast biopsy, colonoscopy, and transrectal prostate biopsy in cancer patients receiving chemotherapy.

Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient. This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest, ocean or space. Virtual reality glasses are an application that is used to isolate the patient from his/her environment and includes a distraction method that allows the patient to focus on another world in three dimensions. It is usually applied with glasses or headgear. In addition, the patient is prevented from perceiving the surrounding sounds by wearing headphones. The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place. The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of time. Virtual reality applications, a new technology, can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients. This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention. The widespread use of virtual reality applications in cancer care contributes to qualified nursing care. This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices.

Study Design and Setting This single-center, single-blind, randomized controlledarasında conducted between July 2023 and July 2024 in the outpatient chemotherapy unit of a tertiary education and research hospital in Western Türkiye. Participants were randomly assigned to either a control group (CG=46) receiving routine care or a VR group (VRG=46) receiving routine care plus a distraction intervention. The VR group received a visual and auditory distraction intervention via VR by watching audio and video clips during the port catheter needle insertion procedure. The control group did not receive any distraction method. Outcome measures were: perceived procedure time, overall comfort level and sublevels, and patient satisfaction. Study Sample The study population consisted of 1,000 cancer paarasındapitalized between January 2022 and January 2023. The effect size of a similar studyby Başak et al. (2020) examining patient satisfaction with distraction-based intervention during peripheral intravenous access was used as a reference for determining the sample size. Power analysis resulted in a total sample size of 70 patients with an α = 0.05 and a power of 0.99. However, due to the risk of data loss during the stdy, the sample size was increased. Therefore, the final sample consisted of 92 cancer patients; 46 in the VR group and 46 in the control group.

Inclusion criteria were being at least açısıylars old, actively undergoing chemotherapy, having stage I, II, or III cancer, having a port catheter, and being willing to participate in the study.

Exclusion criteria included the preseKriterleriastasis, previous virtual reality experience, communication difficulties, and a diagnosed psychiatric disorder.

Data Instruments Study data were collected using the Patient Information Form, General Comfort Scale-Short Form, Time Perception Assessment Form, and Satisfaction Assessment Form.

Data Collection Before the study, patients meeting the inclusion criteria were informed about the purpose of the study and their informed consent was obtained. They were then assigned to either the VR group or the control group using a simple randomization method. Assessments were performed twice, before PCNI (Base Assessment) and after PCNI (T1). In the first assessment, both groups completed the Patient Information Form and the General Comfort Scale-Short Form. In the second assessment, both groups completed the Perceived Time Form and the General Comfort ScalepakettproÖlçeği'niVR group also completed the Satisfaction Assessment Form to measure their satisfaction with the VR application. Data were collected simultaneously in beşzamanlı.

Patients in the VR group were briefed by the researcher about the VR applitestin and the visual content used within it. The VR visual content was displayed via a headset, atestitients were asked to choose one of the available videos. From the available VR content, 12 patMann-Whitneya tropipatients a seascape, 10 patients a sunrise and sunset, 8 patients underwater life, and 5 patients a forest walk. After the patip \< 0,05s positioned in the chemotherapy chair, the VR headset was used for approximately 6 minutes during the port catheter needle insertion procedure. The control group did not receive an intervention in addition to their routine care.

Ethical considerations:

Before the onset of the study, approval was obtained from thePolikliniği Yaklaşıkf a state university (Decision date/number: 2023/1090), and institutional permission was obtained from the hospital where the study was conducted. Participants were informed about the purpveof the research, their consent was obtained, and they were assured that they could withdraw from the study at any time. All principles of the Helsinki Declaration were adhered to at every stage of the study.

Data analysis The study reported descriptive statistics such as number, percentage, mean, standard deviation, minimum and maximum values. The reliability of the scale used in the study was also tested. The assumption of normality was assessed with the Shapiro-Wilk test, and homogeneity of variance was assessed with the Levene test. Tt testipendent Samples t-test was used to compare the means of two independent groups that were normally distributed, while the Mann-Whitney U test was used ,wheşleştirilmiştörneklemot testi was not met. The Paired Samples t-test was used to compare the means of two dependent groups that were normally distributed, while the Wilcoxon signed-rank test was used when normal distribution was not metaksi analyzing categoricakesinatestirson's Chi-Square test was applied when the sample sizet testifficient (expected value > 5); otherwise, Fisher's Exact test was used. The difference between the groups was evaluated with an independent samples t-test, and the effect size was reported with Cohen's d. Importantly, the effect sip \< 0,05 found to be significantly large. The analyses were conducted using IBM SPSS Statistics version 25.0. Statistical significance was accepted at p\<0.05.

Results In terms of sociodemographic characteristics, half of the intervention group were women (50.0%) and more than half of the control group was men (52.2%). Most participants in both groups were married (IG: 80.4%, CG:69.6%), and approximately half of them had only primary school education (VRG: 45.7%, CG:39.1%). Most participants in both groups indicated that they were not working (VRG: 67.4%, CG: 58.7%). Furthermore, more than half of the VR group (54.3%) had another chronic disease, while more than half of the control group (54.3%) did not.

In terms of clinical characteristics, approximately half of the VR group (47.8%) had stage 3 cancer, while most participants in the control group (43.5%) had stage 2 cancer. The majority in both groups reported having had four or more PCNI experiences (VRG: 67.4%, CG:82.6%). Additionally, more than half of the participants in both study groups stated that they had not received education about port catheter use and care (VRG: 60.9%, CG: 69.6%) (Table 1).

There was no statistically significant difference between the study groups (p>0.05) when they were compared in terms of sociodemographic and clinical characteristics as well as port catheter status. Importantly, the distributions of sociodemographic and clinical characteristics as well as port catheter status were homogeneous in the VRG and CG.

Center/Centers Where The Research Conducted; Bursa Uludağ University Faculty of Medicine Hospital Medical Oncology Polyclinic