Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in salivary cortisol levels
研究概览
简要总结
Hospitalization is a stressful event that might impact in a patient's recovery. Children are more susceptible to suffer acute stress as a result of a hospital stay. Stress is often quantized using cortisol levels, a substance which increases following stressful stimuli. Since stress management is important in a patient's recovery, different therapies are used and have been evaluated and proven effective to diminish cortisol levels such as play interventions and clown therapy. Nevertheless, they rely on volunteers or trained staff to perform them. Nowadays, technology such as augmented reality allow us to provide therapy without the need of volunteers. This project aims to test if augmented reality technology is effective in lowering salivary cortisol levels in hospitalized children.
详细描述
Background: Acute stress produced by hospitalization has a direct impact on the patient's recovery. Increased cortisol levels, the biomarker of stress, have been associated to poor health outcomes, especially on pediatric patients. Stress management in the hospital environment is essential to lower the effects of hospitalization but tend to require volunteers or other trained staff. With the advent of augmented reality technologies, providing ludic therapies to children without the need of personnel is possible. Augmented reality (AR) consists in overlapping digital information over physical objects or places creating an unique experience and the possibility of the user to interact with the technology. AR has been used in psychological and physical therapy with notable results. AR books are available in the market and are seen as a great educational tool for children. The aim of this study is to assess the effectiveness of AR books as a stress management tool in the hospital environment in a randomized cross-over study.
Sample size: Calculated taking as reference cortisol values reported previously in hospitalized children in the morning. With a 90% power and a α value of 0.05, a a significant difference of 30% of the value before the intervention is expected. For this, a sample size of 28 participants will be necessary.
Recruitment: Study participants will be recruited and enrolled in the Pediatrics Department of Cayetano Heredia Hospital. After signed consent by parents and written assent by each participant, an envelope with a random code will be opened. This code will have information of which intervention will be performed first. For AR intervention, a book and an electronic tablet will be given to the participant, for the non AR intervention (NoAR) only a book will be given. The book at the first intervention will be different than the book at the second intervention. Salivary samples will be collected before and after the intervention and a visual analogue scale (VAS) will be given to children to self-assess mood. After a 48 hour wash-out, the second intervention will take place.
Statistical analysis plan: The decrease in cortisol levels will be calculated for each participant and for each treatment. The difference in the reduction (DIF) of AR group vs. NoAR will also be calculated. A simple linear regression model will be used with DIF as dependent variable, the independent variable will be the order of intervention. The intercept will be the average decrease difference and the confidence interval will establish the statistical significance. For the secondary outcomes, the VAS will be associated with salivary cortisol.
Plan for missing data: All missing data will be reported as such.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls aged 7 - 11
- •In appropriate conditions to read a book
- •Hospitalization ≥ 3 days
- •Capable of reading in Spanish.
- •Written assent and informed consent signed by parents
排除标准
- •Patients with adrenal diseases such as Cushing's or Addison Disease
- •Patients with steroid prescription
研究组 & 干预措施
Augmented Reality (AR)
Books with augmented reality plus an electronic tablet.
干预措施: Augmented Reality (Other)
Non Augmented Reality (NoAR)
Conventional children book. No electronic device will be given to children.
干预措施: Non Augmented Reality (Other)
结局指标
主要结局
Change in salivary cortisol levels
时间窗: Salivary samples will be obtained before and after the 1 hour intervention and kept under -20ºC until collection of samples of all participants.
Cortisol of salivary samples will be analyzed with a commercial Enzyme Immune Assay kit (DRG , Germany).
次要结局
- Visual analogue scale (VAS)(VAS will be given immediately after salivary collection.)