360° Video VR Surgery Preparation: Feasibility, Acceptability, Tolerability and Initial Effectiveness of Virtual Reality for Children in a Flemish Hospital.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
研究概览
简要总结
Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.
This is one of the case studies from the larger project titled: 360 ° video VR surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a Flemish hospital.
Domain: This scientific study will take place in 1 hospital on the pediatric ward. The target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved.
Target:
- Assess the acceptability, feasibility and tolerability of the 360 ° video VR surgery preparation.
- Assess the effectiveness of the 360 ° video VR surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (CAU *).
- CAU in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be obtained
- •Inpatient or outpatient in the study site (Heilig Hart Hospital Lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021).
- •Age range of ≥ 6 and ≤ 12
- •Normal or corrected-to-normal vision
- •Normal or corrected-to-normal hearing
排除标准
- •Patient has a history of seizure disorders (e.g. epilepsy)
- •Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
- •Non-Dutch/English/French speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
- •Previous enrolment in this study (during a previous hospital stay)
结局指标
主要结局
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
时间窗: Immediately after the intervention
Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options. Higher scores indicate higher satisfaction.
Change from baseline in staff attitude towards the intervention
时间窗: Staff: Measurement takes place in week 5 after the start of the study.
Unified theory of acceptance and use of technology tests the acceptance of the staff towards the intervention in this study. Assess change in patient attitude towards the intervention with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" to "Totally agree". The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the intervention.
Usability of the intervention: System Usability Scale (SUS)
时间窗: Immediately after the intervention.
Assessment of ease of use of the intervention with the System Usability Scale (SUS). The SUS is a 10 item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree". A higher SUS score indicates better usability.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
时间窗: Immediately after the intervention
Assessment of physical side effects after exposure to VR by the Pediatric Simulator Sickness Questionnaire (Peds SSQ). The Peds SSQ contains queries that probe 4 symptom categories: (1) eye strain (queries 1-4); (2) head and neck discomfort (queries 5 and 6); (3) sleepiness (solipsism) or fatigue (queries 7 and 8); and dizziness or nausea (visually induced motion sickness, queries 9-13). The scale that is used is a likert scale (with additional faces) ranging from 0 to 6 per query (0 = no of the above "complaints"; 6 = a lot of the above "complaints".
Intervention adherence
时间窗: Immediately after the intervention
Measure intervention adherence by registering the number of fully completed sessions.
Procedure time
时间窗: Immediately after the intervention
The procedure time of intervention in minutes
次要结局
- Preliminary effectiveness (change in anxiety between timepoints) (Intervention and control)(Measurement 1: Immediately after signing the informed consent, day 1 of study. Measurement 2: Immediately after the intervention, day 1 of study. Measurement 3: Just before surgery, day 4 of study)