The Effect of Virtual Reality-Based Education on Preoperative Surgical Fear, Postoperative Pain and Patient Satisfaction in Patients Undergoing Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Surgical Fear Scale
研究概览
简要总结
Objective: A randomized controlled trial was designed to determine the effect of virtual reality-based education provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain, and patient satisfaction.
Materials and Methods: The study was designed as a randomized controlled experimental study, with the group receiving animation-based patient education via virtual reality goggles serving as the experimental group and the group receiving routine patient education at the clinic serving as the control group. Research data will be collected using a patient characteristics form prepared by the researcher based on a literature review, a surgical fear scale, a visual analog scale, and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.
详细描述
Type of Study The study was designed as a randomized controlled trial to determine the effect of virtual reality training provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain and patient satisfaction.
Location and General Characteristics of the Study The study will be conducted at the Orthopedics and Traumatology Clinic of Ankara Gazi University Health Research and Application Center with patients who meet the study criteria.
Study Population and Sample The study population will consist of patients hospitalized at the Orthopedics and Traumatology Clinic of Ankara Gazi University Health Research and Application Center. Within this scope, the sample of the study will consist of patients selected by randomization from among individuals who will undergo knee arthroplasty surgery, in accordance with the inclusion and exclusion criteria of the study.
Blinding and Prevention of Bias in the Study Assignment to the control and experimental groups will be performed by an independent statistician to prevent bias and ensure confidentiality, and a blind technique will be applied. Thus, selection bias will be controlled by random assignment and concealment of randomization. Since the intervention will be administered by the researcher, double-blinding will not be possible, but the data will be transferred to the computer by the researcher and coded as 'A' and 'B'. Additionally, to prevent bias, the analysis of coded data will be conducted by an independent statistician outside the research team. The study protocol will follow the SPIRIT guidelines, and the research will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2017 checklist.
Data Collection Tools Research data will be collected using a patient characteristics form prepared by the researcher based on a literature review, a surgical fear scale, a visual analog scale (VAS-pain), and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the Study and Prevention of Bias Assignment to control and experimental groups will be performed by an independent statistician to prevent bias and ensure confidentiality, and a blinding technique will be applied. Thus, selection bias will be controlled by random assignment and concealment of randomization. Since the intervention will be administered by the researcher, double-blinding will not be possible, but the data will be coded as 'A' and 'B' by the researcher and transferred to the computer. Furthermore, to prevent bias, the analysis of the coded data will be performed by an independent statistician outside the research team. The study protocol will follow the SPIRIT guidelines, and the reporting of the research will be conducted according to the Consolidated Standards of Reporting Trials (CONSORT) 2017 checklist.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older,
- •Agree to participate in volunteer work,
- •Have no communication problems in terms of vision, hearing, and perception,
- •Be able to read, speak, and understand Turkish,
- •Have no fear of enclosed spaces.
排除标准
- •Bilateral Total Knee Arthroplasty.
- •Admission to the clinic on the day of surgery.
研究组 & 干预措施
Control Group
Patients who agree to participate in the study will be asked to complete a patient characteristics form. Patients in the control group will not receive any specific education from the researcher during the preoperative period. These patients will receive the clinic's routine patient education prior to surgery. After consulting with the nurses who provided the routine patient education at the clinic, the surgical fear scale will be administered. Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 hours. Since the data collection process for our study ends at 24 hours, the patient satisfaction scale will be completed at that time. Data collection is expected to take a total of 15-20 minutes.
Experimental Group
The researcher will provide patients with information about the virtual reality headset. The virtual reality headset will be disinfected before use for each patient. Patients in the experimental group will receive patient education using an animation-based video method with the virtual reality (VR) headset one day before the surgery. The training will be provided in a quiet, calm environment where the training will not be interrupted, in their own rooms for patients staying in single rooms, and in the nurse's room for patients staying in rooms with 2 or more beds. Patient education will be provided using the animation-based video method, and after answering the patient's questions, the surgical fear scale will be applied. Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, 1, 2, 4, 8, 12, and 24 hours. Since the data collection process for our study ends at 24 hours, the patient satisfaction scale will be completed at that ti
干预措施: patient education with virtual reality (Other)
结局指标
主要结局
Surgical Fear Scale
时间窗: one day before the surgery
It is used to determine the fear levels of patients undergoing elective surgery. The scale consists of eight items on an 11-point Likert scale and is scored from zero to ten. The scale consists of two subscales that measure fear related to the short- and long-term outcomes of surgery. Items 1-4 measure fear of the short-term outcomes of the surgical procedure, while items 5-8 measure fear of the long-term outcomes of the surgical procedure. These questions address fears related to the surgical operation, anesthesia, pain, side effects, deterioration of health as a result of the surgical operation, failure of the surgical operation, inability to fully recover after the surgical operation, and prolongation of the recovery process. The items on the scale are rated on a scale of "0: not afraid at all" to "10: very afraid." The highest possible score on the scale is eighty, and the lowest is zero.
次要结局
- Visual Analog Scale-Pain(Upon arrival at the clinic after surgery, pain assessment will be performed using the VAS at 15 and 30 minutes, and at 1, 2, 4, 8, 12, and 24 hours.)
研究者
KAHacıosmanoğlu
PhD student
Ankara Yildirim Beyazıt University