Virtual Reality and Endoscopic Mucosal and Submucosal Dissection: a Patient Centred Experience "VREMRESD"
概览
- 阶段
- 不适用
- 干预措施
- Virtual reality pain distraction
- 疾病 / 适应症
- 未指定
- 发起方
- King's College Hospital NHS Trust
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Mucosal (EMR) and Submucosal Dissection (ESD). EMR and ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. VR, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. This study aims to evaluate its application in improving pain management and reducing sedation use during EMR and ESD.
详细描述
This study utilizes a prospective randomized controlled trial (RCT) design to evaluate the feasibility of incorporating Virtual Reality (VR) as a method for pain management during Endoscopic mucosal and (EMR) Submucosal Dissection (ESD). Participants will be randomized into two groups: one receiving VR sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. The primary endpoint is to assess the feasibility of integrating VR for pain management during EMR or ESD procedures. Eligibility criteria ensure that participants are suitable for the study. Patients must be 18 years or older, scheduled for EMR ESD, able to provide informed consent, and proficient in English. Those with contraindications for EMR, ESD, severe impairments affecting VR use, or conditions contraindicating VR are excluded. Endoscopists must be experienced in EMR and ESD, willing to participate, and fluent in English, with non-ESD practitioners or those unwilling to participate excluded. The study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. Secondary endpoints include the proportion of EMR and ESD procedures completed using VR, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists. Follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on VR's impact. This trial will provide critical data on the potential for VR to enhance patient experience, optimize sedation use, and improve procedural outcomes during EMR and ESD, informing future research and clinical applications.
研究者
入排标准
入选标准
- •Age ≥18 years
- •Able to consent.
- •Fit to use virtual reality.
- •Patients allocated to appropriate EMR/ ESD lists.
排除标准
- •Patients who are unable to consent.
- •Contraindication to use VR including, epilepsy and photosensitivity.
- •Planned other interventional colonoscopy (Polypectomy, Stenting).
- •Visually impaired.
- •Pregnancy.
研究组 & 干预措施
Virtual reality (VR) Arm
The VR arm will have a trial run with the VR headset in the endoscopy admission unit. The VR will then be applied at the start of the procedure. If, during the procedure, the patient requests sedation or pain medication, it will be provided. If the patient wishes to remove the VR headset, they may do so at any time.
干预措施: Virtual reality pain distraction
Standard Arm
The control group will follow the standard local protocol for analgesia and sedation throughout the procedure.
干预措施: Standard analgesia and sedation
结局指标
主要结局
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
时间窗: During the EMR/ESD procedure
This will evaluteed by: The completed numbers of ESD procedure with the use of the VR as an additive measure to recduce the need for analgesia and sedation.
次要结局
- The change in analgesia and sedation used while using the VR.(During the EMR/ESD prcoedure)
- The difference in pain scores between the two groups.(baseline, pre-procedure, immediately after the procedure)
- Patient satisfaction.(immediately after the procedure)
- Endoscopist satisfaction.(immediately after the procedure)