Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.

Conditions
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Hospitalized Child

Intervention / Treatment
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* Other: Augmented Reality
* Other: Non Augmented Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with adrenal diseases such as Cushing's or Addison Disease Patients with steroid prescription

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After enrollment, patients will be allocated in either the AR group or the NoAR group. The order of the intervention will be randomly selected before recruitment. A 48 hour wash-out will take place before the second intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Reality (AR)<br>Books with augmented reality plus an electronic tablet. | Other: Augmented Reality<br>* Augmented reality children books. The books will have special markers. The device's camera will read the marker and show 2d and 3D animations with the book's theme.<br>|
| Other: Non Augmented Reality (NoAR)<br>Conventional children book. No electronic device will be given to children. | Other: Non Augmented Reality<br>* Augmented reality book without electronic device. Since no electronic device will be provided, the children will not be able to see any augmented reality features of the book, making it a conventional children's book.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in salivary cortisol levels | Cortisol of salivary samples will be analyzed with a commercial Enzyme Immune Assay kit (DRG , Germany). | Salivary samples will be obtained before and after the 1 hour intervention and kept under -20ºC until collection of samples of all participants. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | A pictograph scale, caricatures of children with different mood going from 1 (crying) to 5 (very happy) given to children to self - assess mood. | VAS will be given immediately after salivary collection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospitalized child, salivary cortisol, augmented reality