Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients
Condition: Hospitalized Child
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Augmented Reality; Non Augmented Reality
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Other
Keywords: hospitalized child; salivary cortisol; augmented reality