Hospitalized Child Clinical Trial
Official title:
Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.
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.
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.
;