Using Virtual Reality Distraction and Disassociation (VRDD) in Adult Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire
研究概览
简要总结
The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication skills. Due to the increasing popularity of Virtual Reality (VR) in the gaming world, VR equipment have been used in children as a safe and effective distraction method during GI endoscopy, removing the need for them to have general anaesthesia for their procedure. This has been thought of as an option for the adult patients which would also save them from requiring sedation for their endoscopy procedure.
This is a pilot feasibility study (small scale preliminary study) carried out at a single hospital site with a dedicated GI endoscopy service. We intend to find out whether the VR headset that is used is tolerated and accepted by adult patients during their endoscopy procedure. This has been shown to be a cheaper option compared to giving sedation drugs or general anaesthesia as well. If adult patients can accept this option, we are hoping to investigate in future larger studies whether they could potentially use this as a distraction method to help improve their experience of undergoing GI endoscopy. Any adult patient who is having an upper GI endoscopy could be potentially eligible. Their endoscopy procedure forms part of their clinical care whereas the research component involves them wearing the VR headset before and/or during their procedure. Their experience of undergoing upper GI endoscopy and wearing the VR headset will be measured using a series of questionnaires.
详细描述
Study design:
This is a small scale preliminary study (pilot feasibility study) which is split into 2 stages. In the first stage, it will investigate if the VRDD equipment is acceptable for an adult patient to use prior to any upper GI endoscopy, including sedated and unsedated procedures. In the second stage, it will investigate whether the VRDD equipment is acceptable specifically for adult patients who have unsedated transnasal endoscopy (TNE). This study will be carried out by the research team who are based at one National Health Service (NHS) hospital i.e. South Tyneside District Hospital in the United Kingdom. The study is funded by EvoEndo, Inc which is based in Colorado, USA (provision of VR equipment). The investigators aim to recruit approximately 30 participants to the study, all of whom will have been referred for an upper GI endoscopy procedure for any clinical reason.
Once a patient has expressed their interest, they will be provided with a participant information sheet to read through. A research team member will be available to answer any queries. Patients who are keen to participate in the study will be asked to sign a consent form for them to be officially recruited into the study. This can be done a few days prior or on the day of their endoscopy procedure. It will be made clear to them that their endoscopy procedure will go ahead regardless of their participation in research because the procedure itself is part of standard clinical care and not research. They will need to sign a separate NHS consent form specifically for the upper GI endoscopy procedure which will be handled by the endoscopy team.
The VR equipment comprises of a headset which the participants will wear right before their procedure. It can play virtual reality images or videos from a mobile phone attached to the front of the headset. The VR content has been provided by the funding body (EvoEndo, Inc) which includes classic television programmes, sports programmes, movies, documentaries and children's entertainment.
Stage 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred with a clinical need for upper GI endoscopy (either transnasal or per oral route) on an elective basis.
排除标准
- •Planned therapeutic procedures (including but not limited to polypectomy, balloon dilatation, stenting).
- •Uncorrected visual or auditory impairments or adaptions (e.g. spectacles) that make wearing the VR equipment difficult.
- •Cognitive impairment or learning disabilities.
- •Epilepsy.
- •Balance disorders.
- •Referred for urgent or emergency GI endoscopy.
- •Withdrawal criteria:
- •Patients who withdraw consent from study participation.
- •Patients who withdraw consent for having the endoscopy procedure.
- •Patients who request to remove the VRDD equipment during Stages 1 or 2 of the study.
结局指标
主要结局
Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire
时间窗: 2-3 months
The acceptability and tolerability of using VRDD in all adult patients referred for upper GI endoscopy, measured on Likert scale via VRDD questionnaire
次要结局
- Acceptability of VRDD in unsedated TNE using VRDD questionnaire(2-3 months)
- Patient experience of using VRDD while having unsedated TNE using Newcastle ENDOPREM™ and mGHAA-9 questionnaires(2-3 months)