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临床试验/NCT06292663
NCT06292663已完成不适用

Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? A Randomized Controlled Trial and Patient Interviews

Zealand University Hospital2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年3月5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
入组人数
88
试验地点
2
主要终点
Preoperative anxiety

研究概览

简要总结

The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:

  • Can preoperative information through a VR headset lower the patients preoperative anxiety?
  • Can VR information make the patients more ready for surgery. Painscore will also be collected.

Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.

If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain

详细描述

Knee osteoarthritis (OA) causes pain, disability and poor quality of life in the elderly. Consequently, it can severely affect people's quality of life and physical function. International guidelines recommend exercise therapy alongside patient education and weight management (if needed) as first-line treatment for all individuals with knee OA. However, more than 1,000,000 TKA procedures are performed annually worldwide, and with aging populations and an increase in obesity, this number is expected to increase markedly4. Although TKA is generally considered an effective treatment option, up to 20% of patients are not fully satisfied after surgery5. Spinal anesthesia is commonly used during primary TKA given the purported safety benefits, quicker immediate postoperative recovery, decreased intraoperative bleeding, and lower transfusion rates when compared to general anesthesia. To help the patient feel more comfortable and relaxed during a procedure, administration of sedative medication titrated by the anesthetist is common practice. Despite a low rate of complications associated with spinal anesthesia compared to general anesthesia, it is important to acknowledge that complications can still occur.

Virtual Reality (VR) demonstrates signs as a promising tool to support healthcare, including mentally preparing the patient for a surgical procedure. Preoperative readiness, expectations, anxiety, and pain perception are crucial to the patient's surgical experiences. VR can immerse patients into a virtual environment and distract patients from e.g., unpleasant sounds, sights, and feelings. Integrating VR into preoperative care has shown the potential to offer several advantages, such as promoting patients' distraction, knowledge, and information. However, harms have been reported such as cyber sickness but only in few cases among older adult patients.

Offering a controlled environment where patients can familiarize themselves with the surgical process through VR shown on a head-mounted display (HMD) and with sound reduction headphones provides them an opportunity to explore, e.g., the operation theater, waiting area, and PACU.

All this can foster a sense of confidence and increased readiness and lead to an overall improved patient experience.

Ethical considerations: this trial will assess the effects of using a VR patient journey preoperatively. Therefore, the trial will be highly systematic and at low risk of producing biased results. The trial will be adequately powered to limit the risk of random error. The participants receiving standard of care will likely not benefit directly from the trial. However, the participants in the control group will potentially assist with valuable evidence, which might benefit future patients. Participants can, at any time, for any reason, withdraw their consent to participate in the trial. If participants withdraw from the trial, it will not impact the level of care and treatment offered by the departments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The primary investigator will stay blinded in this study and an assistant to the investigator is screening and including the patients and collecting data.

入排标准

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

入选标准

  • Scheduled for total knee arthroplasty
  • Scheduled for spinal anesthesia
  • Age of 18 or above
  • Ability to understand the trial protocol, risks, and benefits and provide signed informed consent

排除标准

  • Inability to read and understand Danish
  • Uncooperativeness (as judged by investigators)
  • Claustrophobia or fear of small spaces
  • Disorders that prevent the person from wearing a VR device
  • Highly visually or auditive impaired

研究组 & 干预措施

Control Group

No Intervention

Patients allocated to this group are only getting standard information from their anesthesiologist.

Intervention

Experimental

Patients allocated to this group are getting the standard information from their anesthesiologist and a supplement of information via. a Virtual Reality (VR) headset. The information they get through the VR headset is about their course on the day of their surgery.

干预措施: Virtual Reality (Device)

结局指标

主要结局

Preoperative anxiety

时间窗: On the 1 day of inclusion and on the 1 day of the patient's surgery

Anxiety will be measured by using The Amsterdam Preoperative Anxiety and Information Scale (APAIS). The questionnaire contains six questions addressing topics: worries about the anesthetic, need for information about the anesthetic, worries about the procedure, and need for information about the procedure. Furthermore, the patients fill out the Numerical Rating Scale (NRS) according to anxiety rating from 0-10. 0 is no anxiety at alle, and 10 is the worst imaginable anxiety.

次要结局

  • Adverse events(From the beginning of the intervention and until the end of the intervention period (48 hours postoperatively).)
  • Patient preoperatively expectations(On the 1 day of inclusion)
  • Patient preoperatively readiness(On the 1 day of inclusion and on the 1 day of the patient's surgery)
  • Cumulative sedative consumption(On the 1 day of the patient's surgery)
  • Opioid consumption(On the 1 day of the patient's surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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