The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Trait-Anxiety at baseline
研究概览
简要总结
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.
Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.
Study design: Single-center, randomized controlled trial
Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.
详细描述
Patients undergoing cardiothoracic surgery are inclined to experience a form of pre-procedural anxiety. Not only can these feelings of concern cause huge psychological discomfort for patients awaiting surgery, but this can also translate into somatic complications, especially for patients with coronary artery disease. These adverse events include a prolonged recovery time, increased risk of re-hospitalization and death amongst other implications and underline the necessity of addressing pre-procedural anxiety. Several approaches have been introduced in an attempt to contain these feelings of concern. Examples that have been applied in the field of surgery include pharmacological interventions as well as extensive patient education. Especially the latter has recently been proven to be effective in diminishing pre-procedural anxiety.
A recent study highlighted the significance of 360-degree Virtual Reality patient education in limiting pre-procedural anxiety levels in patients undergoing percutaneous atrial septal closure. Their research demonstrated that thorough patient education using VR could prevent elevated scores of anxiety, possibly contributing to a diminished number of adverse events in this patient group. Alongside this study, several other researches have hinted at success or are investigating the benefit of VR in managing anxiety levels.
Considering these promising results, the aim of the VR Patient Journey Trial is to evaluate the additional value of 360-degree Virtual Reality as a new modality in reducing pre-procedural anxiety in comparison with regular forms of patient education in patients undergoing coronary artery bypass grafting (CABG) procedures. This procedure remains the most performed type of cardiac surgery and accounts for a large homogenous patient group; an estimated 85% of procedures concern isolated CABG. Managing anxiety levels in this patient group can therefore greatly impact the overall level of patient well-being in cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Prior to visiting the outpatient clinic, patients are unaware about their allocation. Only after their outpatient clinic visit, patients are informed about whether they belong to the control or intervention group. The surgeon, nurses OR assistants, however, are not informed about the treatment allocation. This is only known to the investigators and outcomes assessors.
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
- •Patients awaiting elective cardiac surgery involving a sternotomy
- •18 years or older
排除标准
- •Under the age of 18
- •History of previous cardiac surgery
- •(concomitant) aortic surgery
- •Cardiac surgery for congenital heart defects
- •Hearing or visual impairments
- •Language barriers (inability to understand, speak or read Dutch)
- •History of severe mental or psychiatric disorders
结局指标
主要结局
Trait-Anxiety at baseline
时间窗: During outpatient clinic visit, prior to surgery
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Need-for-information at baseline
时间窗: During outpatient clinic visit, prior to surgery
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Pre-procedural anxiety at baseline
时间窗: During outpatient clinic visit, prior to surgery
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
HR at baseline
时间窗: During outpatient clinic visit, prior to surgery
Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery
Systolic blood pressure at follow-up
时间窗: 1 day prior to surgery
Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
State-Anxiety at baseline
时间窗: During outpatient clinic visit, prior to surgery
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Trait-Anxiety at follow-up
时间窗: 1 day prior to surgery
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
HR in operation room
时间窗: in the OR on the day of surgery
Heartrate in bpm (beats per minute) in the operation room on the day of surgery
Diastolic blood pressure at baseline
时间窗: During outpatient clinic visit prior to surgery
Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Systolic blood pressure at baseline
时间窗: During outpatient clinic visit prior to surgery
Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Diastolic blood pressure at follow-up
时间窗: 1 day prior to surgery
Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
State-Anxiety at follow-up
时间窗: 1 day prior to surgery
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Need-for-information at follow-up
时间窗: 1 day prior to surgery
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Pre-procedural anxiety at follow-up
时间窗: 1 day prior to surgery
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
HR at follow-up
时间窗: 1 day prior to surgery
Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)
Diastolic blood pressure in OR
时间窗: in the OR on the day of surgery
Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery
次要结局
未报告次要终点
研究者
Jolanda Kluin
Professor of Cardiothoracic Surgery
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)