Virtual Reality as a Non-pharmacological Tool for Pain and Anxiety Relief During Elective Procedures in the Cathlab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab).
To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling.
Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention.
The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain.
Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective.
The outcomes of the two groups will be statistically compared using the SPSS software package.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the visual presence of the VR, masking is not feasible.
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
- •Undergoing elective procedure in line with the following criteria in the cathlab of the UZB: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (Stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours.
- •Agreeing to participate via signed informed consent.
- •Being at least 18 years of age.
- •Being fluent in either English, French or Dutch language.
排除标准
- •Ailments which would make wearing of the headset uncomfortable or impossible.
- •cognitive impairment such as dementia or delirium.
- •Severe hearing impairment, as this will limit the immersion.
- •Severe visual impairment not compensated by glasses, such as blindness.
结局指标
主要结局
Anxiety
时间窗: State trait: 30 minutes pre operatively and 5 minutes post operatively. Anxiety using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
perioperative anxiety consisting of State, trait anxiety and anxiety experienced during the procedure. State anxiety: level of anxiety a person experiences in the current moment. Trait anxiety: Level of anxiety a person experiences in general, how anxious a person is in general. State and trait anxiety will be measured using the state trait anxiety inventory questionnaire consisting of 20 questions for state anxiety and 20 questions for trait anxiety. The questions are answered in the form of Likert scales ranging from 1 to 4. Anxiety experienced during the procedure will be measured using the visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
Pain experienced during the procedure
时间窗: using VAS: 5 min pre operatively for baseline and 5 minutes post operatively.
The level of pain a patient experienced throughout the elective procedure measured using the Visual analogue scale (VAS) which ranges from 0 (none) to 100 mm (worst imaginable).
次要结局
- Heart rate(At the start of the procedure and every 15 minutes.)
- Satisfaction with VR (for patient, nurses and doctors)(5 minutes after the procedure)
- Diastolic blood pressure(At the start of the procedure and every 15 minutes.)
- Mean Blood pressure(At the start of the procedure and every 15 minutes.)
- Operator comfort (nurses and doctors).(5 minutes after the procedure.)
- Systolic blood pressure(At the start of the procedure and every 15 minutes.)
- Procedural comfort(5 minutes after the procedure)
- Nausea(5 minutes after the procedure)