Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy in University Kebangsaan Malaysia Medical Centre (UKMMC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality) using questionnaire, (0 - not satisfied, 5 extremely satisfied)
研究概览
简要总结
Flexible bronchoscopy is an important procedure used worldwide in the diagnosis and treatment of the disease of the of the lungs and airways . Flexible bronchoscopy is an invasive procedure that is utilized to visualize the nasal passages, pharynx, larynx, vocal cords, and tracheal bronchial tree. It is utilized for both the diagnosis and treatment of lung disorders. The procedure may be performed in an endoscopy suite, the operating room, the emergency department, a radiology suite, or at the bedside in the ICU. Flexible bronchoscopy (FB) is a safe procedure widely used in the management of patients with respiratory diseases. FB has close to zero mortality, and major complications are also very rare. Besides being safe and accurate, the comfort of the patient during the procedure is of primary concern of the medical and endoscopy staff.
Flexible Bronchoscopy can be a frightening and painful experience for the patient. There is room to improve the management of pain during FB, as many patients experience pain despite the common use of premedication analgesics and sedatives. In addition, because.
these medications have side effects, including respiratory depression and cardiovascular instability, it would be useful to develop nonpharmacologic approaches to improving the patient experience with painful procedures. The use of less medication may speed recovery from the procedure and facilitate the timely discharge of patients from the hospital. Nonpharmacologic practices, such as guided imagery, hypnosis, and distraction, have been effective in improving patient experiences during stressful or painful medical procedures. Distraction therapy is a technique in which sensory stimuli are provided to patients in order to divert their attention from an unpleasant experience. The use of nature scenes and sounds is an effective tool for distraction and has been successful in a variety of patient settings, including perioperative care, phlebotomy, and burn care. The benefit of nonpharmacologic approaches to analgesia during FB, however, has not been evaluated adequately. A visual reality (VR) device is an apparatus with a head up display (HUD) that projects a video and contains sound, the device is aimed to replace the patient's natural environment with virtual reality content. The use of Virtual reality(VR) device during flexible bronchoscopy has not been studies before.
详细描述
PROBLEM STATEMENT In Malaysia, flexible bronchoscopy has been well established in many respiratory centers as a means of diagnosis and treatment for many respiratory diseases, however there not many studies into use of nonpharmacological methods of improving patients experience during bronchoscopy. The use of conventional analgesia and sedation is considered standard of care during flexible bronchoscopy. In Respiratory centers, and our own center, Pusat Perubatan UKM (PPUKM), bronchoscopists use fentanyl and midazolam routinely as a means of analgesia during flexible bronchoscopy. There has not been research into the use of Virtual reality (VR) as a method of distraction to reduce anxiety and improve satisfaction in patient undergoing bronchoscopy. Investigators aim to carry out a randomize control trial, to study and compare the use Virtual Reality (VR) device in subjects undergoing flexible bronchoscopy. There are many parameters which the investigators will be looking into, the first will be overall subject's satisfaction with bronchoscope. Investigators will also compare parameter such as anxiety levels during the procedure, pain, cough and also breathlessness.
RESEARCH QUESTION Can VR (Virtual reality) device be used to improve satisfaction, reduce anxiety, pain cough and breathlessness for patients undergoing flexible bronchoscopy
HYPOTHESIS VR device can improve patient's satisfaction of flexible bronchoscopy by using methods of distraction.
VR device can reduce patient's anxiety during flexible bronchoscopy. VR device can reduce patient's pain during flexible bronchoscopy. VR device can reduce patient's cough during flexible bronchoscopy. VR device can reduce patient's breathlessness during flexible bronchoscopy.
OBJECTIVE General To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age 18 years old and above
- •Patient undergoing flexible bronchoscopy.
- •understand and able to give consent (understand English and Malay)
- •patient will need a negative covid PCR test as per standard practic
排除标准
- •Age < 18
- •Unable to understand and give consent (does not understand English, Malay)
- •Ventilated patient
- •Patient who are not comfortable wearing VR device
- •Patient who are unable to communicate (illiterate, hearing impairment, mute, blind, Memory impairment)
- •Patient on other sedation other than midazolam/fentanyl
- •Patient undergoing other invasive examination planned alongside bronchoscopy.
- •Patient with earlier history of bronchoscopy
- •Patient with cranial-facial deformity
研究组 & 干预措施
Patient undergoing Bronchoscopy without use of VR device
patients undergoing flexible bronchoscopy without the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice.
Patient Undergoing Bronchoscopy with the use of VR device
patients undergoing flexible bronchoscopy with the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice.
干预措施: Virtual Reality Device (Device)
结局指标
主要结局
To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality) using questionnaire, (0 - not satisfied, 5 extremely satisfied)
时间窗: 6 months
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given satisfaction questionnaire to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
次要结局
- to compare pain of patient undergoing flexible bronchoscopy with or without VR (virtual reality), using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)(6 months)
- to compare breathlessness of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)(6 months)
- to compare cough of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)(6 months)
- to compare anxiety of patient undergoing flexible bronchoscopy with or without VR using Stat Trait Anxiety Index (STAI) questionairre.(6 months)
研究者
Mohamed Faisal Abdul Hamid
Associate Professor
National University of Malaysia