Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)
研究概览
简要总结
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
详细描述
Current pain and anxiety management for children in hospital includes pharmacological analgesia (e.g. opioid therapy) with potential negative side effects. In addition, a non-pharmacological approach involves various distraction techniques, either passive (e.g., music, movies) or active (e.g., interactive toys, electronic games, storytelling by the nursing staff). However, these distraction techniques can often be time consuming for the already busy and even over-demanded nursing staff.
A combination of distraction, extinction learning, cognitive-behavioral principles, mindful meditation, stress reduction, gate-control theory, and the spotlight theory of attention is believed to be the mechanism behind VR's effectiveness in pain management. Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures, intravenous injections, burn wound care and rehabilitation. In particular, a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain (14 studies) and anxiety (7 studies) than care as usual (CAU), with large effect size. Moreover, for chest radiography, the use of VR has also significantly reduced procedure time, while increasing patient satisfaction. As such, adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice.
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 16 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 one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo treatment or a single medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff*.
- •For example (but not limited to), for the relaxation module of the VR intervention, following paediatric patients can be recruited: paediatric patients awaiting surgery, paediatric patients post-surgery during their (brief) stay in the recovery unit, paediatric patients staying at the oncological department, paediatric patients with eating disorders in need of relaxation after having eaten, or paediatric patients experiencing psychosomatic complaints (e.g. stomach ache).
- •For example, for the distraction module of the VR intervention, following paediatric patients can be recruited: paediatric patients undergoing a single medical (nursing procedure) such as (but not limited to) wound care, blood draw or vaccination.
- •Age range of ≥ 4 and ≤ 16
- •Normal or corrected-to-normal vision
- •Normal or corrected-to-normal hearing
- •Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study. In a real-life situation, the clinical staff chooses appropriate care methods (e.g. means of distraction or medication) based on their clinical expertise (in addition to treatment and pain management protocols). Therefore, the overall feasibility, acceptability, tolerability and initial clinical effect of the VR application are explored for an 'as-broad-as-possible' population, in order to provide information on what works best for whom with respect to Relaxation-VR. This practice-oriented approach allows us to investigate the potential of a VR intervention for a larger population, which could have the largest impact for the paediatric population and the clinical staff.
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)
- •Patient will undergo a medical procedure or treatment that is considered unsuitable in combination with the use of a VR headset, as assessed by the clinical staff (e.g., facial wound care)
- •Non-Dutch native 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
Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)
时间窗: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions.
Feasibility as assessed by the paediatric participants
时间窗: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. Ease of use assessed with Visual Analogue Scale (VAS) ranging from 0 (very easy) to 100 (very difficult). Fun assessed with Visual Analogue Scale (VAS) ranging from 0 (A lot of fun to 100 (No fun at all).
Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire)
时间窗: Immediately after the intervention.
This questionnaire is based on the Simulator Sickness Questionnaire (SSQ) and is used to assess physical adverse events due to the VR intervention. The query language of the SSQ was simplified for children and modified Wong-Baker faces were added to create a Peds SSQ, with a score of 0 (happy face) indicating no adverse event and a score of 6 (unhappy face) indicating more severe adverse event. The Peds SSQ, in accordance with the SSQ, contains queries that probe four symptom categories: eye strain, head and neck discomfort, sleepiness or fatigue, and dizziness or nausea. A lower score indicates a better outcome.
Feasibility as assessed by a parent of the paediatric patient
时间窗: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. E.g. Did the child keep the VR-headset on during the entire procedure?
Acceptability as assessed by a parent of the paediatric patient
时间窗: Immediately after the intervention
Survey comprised of a combination of open-ended and response-set questions. E.g., Why did you want to try it? Would you use it again?
次要结局
- Changes in pain levels from pre-to-post intervention session: Faces Pain Rating Scale-Revised (FPRS-R)(Immediately before and after the intervention.)
- Changes in anxiety levels from pre-to-post intervention session: Visual Analogue Scale (VAS)(Immediately before and after the intervention.)
- Changes in emotion (happiness and arousal/stress) levels from pre-to-post intervention session: Two items of the Self-Assessment Manikin (SAM)(Immediately before and after the intervention.)