Virtual Reality: An Innovative Approach to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pain at energy level 900
研究概览
简要总结
The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements.
The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group.
The secondary outcomes are as follows:
- Type and dose of analgesia
- Conductance scores/values
- Anxiety levels
- Patient satisfaction
- Procedure duration
- Adverse events
Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not
详细描述
The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shockwave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements.
Furthermore, the study aims to gather data on patients' perspectives regarding the functionality and efficacy of VR technology in enhancing their intraprocedural experience. This includes an evaluation of VR's role in contribution to the overall procedural experience.
Introduction: According to the European Association of Urology (EAU) guidelines, urolithiasis is treated with ESWL, Ureteroscopy (URS), Percutaneous Nephrolithotomy (PNL), or other surgical treatments that may relieve the obstructive symptoms of the urinary tract. EAU recommends ESWL as the primary treatment for renal pelvic and proximal ureteral stones of <20 mm. The success of ESWL is closely related to factors such as the experience of the urologist using the machine, localization of the stone, urinary system anatomy, and the patient's compliance with the procedure. To ensure compliance, it is important to minimize patients' pain and anxiety. To handle pain and anxiety, various ways including both pharmacological and non-pharmacological approaches are in use today. Pharmacological control of pain and anxiety, including the use of sedation, is a complex decision that consider both benefits and potential risks. While not highly recommended due to the side effects associated with these agents, such as hypotension, respiratory depression, confusion, and limitations in ability to operate machines, sedation medication can be an effective means of managing pain and anxiety when used judiciously.
Non-pharmacological alternatives have been recommended for decreasing pain and anxiety during ESWL, as for example music which have been found beneficial in several studies. VR can immerse patients into a virtual environment and distract patients from e.g., unpleasant sounds, sights, and feelings. Integrating VR into hospital settings, has shown the potential to offer several advantages, such as promoting patients' distraction, knowledge, and information. The advantage lies in the engagement of multiple sensory perceptions, including hearing and vision, which can be beneficial in enhancing the potential for reduced experiences of pain and anxiety, as these perceptions typically strengthen humans' cognitive memory. The hypothesis is that distraction from VR can lower pain perception and reduce anxiety for patient undergoing EWSL compared with standard care.
Virtual Reality (VR) has been widely used in psychiatry and for children when they need to have a peripheral venous catheter inserted. Many studies show that VR has a distracting effect, and this distraction can be used to reduce both pain and anxiety. The novelty of this research study lies in using VR during ESWL so that the patient experiences less pain and anxiety. There is only one study from 2023, conducted in Belgium, which investigates whether VR is effective in reducing pain in kidney stone patients during ESWL. This study is a randomized controlled trial (RCT), and its results support the use of VR as a method for pain relief during ESWL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Due to the nature of VR, it is impossible to mask the patients and the healthcare providers administering the shockwave treatment.
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
- •Scheduled for ESWL at Region Zealand
- •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
结局指标
主要结局
Pain at energy level 900
时间窗: The outcome measure will be assessed from the start of the patient's ESWL treatment until the end of the procedure, with an average treatment duration of approximately 45 minutes.
Data about the pain is registered at energy level 900 during the ESWL treatment for the intervention and the control group. The pain is measured by using the Numeric Rating Scale rating from 0-10. Zero is no pain at all and 10 is the worst imaginable pain. The outcome measure will be assessed during the patient ESWL treatment when the energy level of 900 is reached.
次要结局
- Patient Satisfaction(The outcome measure will be assessed by the patient 1 hour or less after the ESWL treatment have ended.)
- Adverse events(The outcome measure will be noted during or less than 1 hour after the ESWL treatment is finished.)
- Procedure duration(Measurements will be recorded for each individual during the treatment approximately 45 minutes.)
- Pre- and intraprocedural pain(Measurements will be taken at the day for treatment for each individual. At arrival at preperations room and during the patients ESWL treatment approximately 2 hours time frame..)
- Anxiety(Measurements will be taken at the day for treatment for each individual. At arrival at preperations room and during the patients ESWL treatment approximately 2 hours time frame.)
- Conductance score/values(The outcome measure will be assessed from the start of the patient's ESWL treatment until the end of the procedure, with an average treatment duration of approximately 45 minutes.)
- Type and dose of analgesia(The outcome measure will be assessed from the start of the patient's ESWL treatment until the end of the procedure, with an average treatment duration of approximately 45 minutes.)