Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT03537859|
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hospitalized Child||Other: Augmented Reality Other: Non Augmented Reality||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|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)|
|Official Title:||Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.|
|Actual Study Start Date :||June 5, 2018|
|Actual Primary Completion Date :||January 18, 2019|
|Actual Study Completion Date :||January 18, 2019|
Experimental: Augmented Reality (AR)
Books with augmented reality plus an electronic tablet.
Other: Augmented Reality
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.
Non Augmented Reality (NoAR)
Conventional children book. No electronic device will be given to children.
Other: Non Augmented Reality
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.
- Change in salivary cortisol levels [ Time Frame: 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).
- Visual analogue scale (VAS) [ Time Frame: VAS will be given immediately after salivary collection. ]A pictograph scale, caricatures of children with different mood going from 1 (crying) to 5 (very happy) given to children to self - assess mood.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537859
|Hospital Cayetano Heredia|
|Lima, Peru, 15102|
|Principal Investigator:||Dulce E. Alarcón-Yaquetto, BSc||Universidad Peruana Cayetano Heredia|
|Study Director:||Cesar P Cárcamo, MD PhD||Universidad Peruana Cayetano Heredia|