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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
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief 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.

Condition or disease Intervention/treatment Phase
Hospitalized Child Other: Augmented Reality Other: Non Augmented Reality Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537859


Locations
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Peru
Hospital Cayetano Heredia
Lima, Peru, 15102
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
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Principal Investigator: Dulce E. Alarcón-Yaquetto, BSc Universidad Peruana Cayetano Heredia
Study Director: Cesar P Cárcamo, MD PhD Universidad Peruana Cayetano Heredia

Publications:

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03537859     History of Changes
Other Study ID Numbers: SIDISI 101432
036-018 ( Other Identifier: Hospital Cayetano Heredia )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Study Protocol in spanish and english will be available. As well as the Statistical Analysis Plan and the informed consent and assent forms (in spanish)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: May 15, 2018
Access Criteria: Open Access
URL: https://osf.io/5q8ha/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad Peruana Cayetano Heredia:
hospitalized child
salivary cortisol
augmented reality

Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents