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临床试验/NCT06551753
NCT06551753已完成不适用

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

Uludag University2 个研究点 分布在 2 个国家目标入组 92 人开始时间: 2023年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
beginning

研究概览

简要总结

This study is a randomized controlled experimental study planned to examine the effect of 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, changing heir perception of space and time. It has been shown that virtual relity 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

Given the nature of the intervention, the investigator and patients were not blinded to the intervention. Since the patients in the intervention group were fitted with virtual reality glasses, blinding could not be performed due to the nature of the study. However, patients were blind to randomization until administration began. After the patient was pre-tested, he was informed by the researcher that he was in the intervention or control group. The investigator was also blind to randomization. Patients were assigned to intervention and control groups by an independent selection from a simple bag of random numbers prepared for randomization. Analysis of the study data was also performed by an independent statistician who was unaware of the intervention and control groups. In this study, blinding was ensured in the implementation of randomization and analysis and reporting of data.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being at least 18 years old, actively undergoing chemotherapy, having stage I, II, or III cancer, having a port catheter, and being willing to participate in the study.

排除标准

  • Presence of metastases, previous virtual reality experience, communication difficulties, and a diagnosed psychiatric disorder.

研究组 & 干预措施

virtual reality app

Experimental

virtual reality app

干预措施: virtual reality app (Other)

结局指标

主要结局

beginning

时间窗: Before port needle placement

Before the procedure, patient information form, satisfaction assessment scale, general comfort scale-short form were filled out in both groups. General Comfort Scale - Short Form: This form was developed by Kolcaba in 2006. Its Turkish validity and reliability were determined by Saritas and colleagues. The scale consists of 28 items and includes three dimensions: relaxation, calmness, and coping with problems. The items in the scale are scored on a 6-point Likert scale from "strongly disagree" (1) to "strongly agree" (6). There are both positive and negative items. For scoring, negative items are reverse-coded, all items are summed, and the total is divided by the number of items to obtain the average score. The lowest possible score of 1 indicates low comfort, and the highest possible score of 6 indicates high comfort. The Cronbach alpha value of the scale was found to be 0.82.

次要结局

  • finish(after port needle placement)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra ibek

Oncology Clinic Nurse

Uludag University

研究点 (2)

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