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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 18, 2019

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Augmented Reality (AR)
    • Books with augmented reality plus an electronic tablet.
  • Other: Non Augmented Reality (NoAR)
    • Conventional children book. No electronic device will be given to children.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Peruana Cayetano Heredia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dulce E. Alarcón-Yaquetto, BSc, Principal Investigator, Universidad Peruana Cayetano Heredia
    • Cesar P Cárcamo, MD PhD, Study Director, Universidad Peruana Cayetano Heredia

References

Bsiri-Moghaddam K, Basiri-Moghaddam M, Sadeghmoghaddam L, Ahmadi F. The concept of hospitalization of children from the view point of parents and children. Iran J Pediatr. 2011 Jun;21(2):201-8.

Mindru DE, Stanescu RS, Mioara CM, Duceac LD, Rugina A, Temneanu OR, Ungureanu M, Florescu L. STRESS IN PEDIATRIC PATIENTS–THE EFFECT OF PROLONGED HOSPITALIZATION. Rev Med Chir Soc Med Nat Iasi. 2016 Apr-Jun;120(2):417-23.

Potasz C, De Varela MJ, De Carvalho LC, Do Prado LF, Do Prado GF. Effect of play activities on hospitalized children's stress: a randomized clinical trial. Scand J Occup Ther. 2013 Jan;20(1):71-9. doi: 10.3109/11038128.2012.729087. Epub 2012 Oct 18.

Saliba FG, Adiwardana NS, Uehara EU, Silvestre RN, Leite VV, Faleiros FT, Padovani FH, De Gobbi JI. Salivary Cortisol Levels: The Importance of Clown Doctors to Reduce Stress. Pediatr Rep. 2016 Mar 31;8(1):6188. doi: 10.4081/pr.2016.6188. eCollection 2016 Mar 31.

Berryman DR. Augmented reality: a review. Med Ref Serv Q. 2012;31(2):212-8. doi: 10.1080/02763869.2012.670604.

Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3.

McCarthy AM, Hanrahan K, Kleiber C, Zimmerman MB, Lutgendorf S, Tsalikian E. Normative salivary cortisol values and responsivity in children. Appl Nurs Res. 2009 Feb;22(1):54-62. doi: 10.1016/j.apnr.2007.04.009.

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