Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
研究概览
简要总结
Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.
In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 6-18 years
- •port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic
- •hematological or oncological diagnosis
- •informed consent
排除标准
- •coronary artery disease
- •history of severe vertigo
- •obstacles to putting on and wearing VR glasses
- •lack of informed consent for study participation.
结局指标
主要结局
Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
时间窗: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)
时间窗: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)
时间窗: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
Virtual Reality vs. Standard-of-Care
次要结局
- Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)(through study completion, ~ 1.5 years in total)
- Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)(post-interventional (immediately after the intervention))