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

NCT03537859 | Completed

• 2 other identifiers: SIDISI 101432036-018
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalized Child

Keywords

hospitalized child; salivary cortisol; augmented reality

Outcome Measures

Primary Outcomes (1)

• Change in salivary cortisol levels

  Cortisol of salivary samples will be analyzed with a commercial Enzyme Immune Assay kit (DRG , Germany).

  Salivary samples will be obtained before and after the 1 hour intervention and kept under -20ºC until collection of samples of all participants.

Secondary Outcomes (1)

• Visual analogue scale (VAS)

  VAS will be given immediately after salivary collection.

Study Arms (2)

Augmented Reality (AR)

EXPERIMENTAL

Books with augmented reality plus an electronic tablet.

Other: Augmented Reality

Non Augmented Reality (NoAR)

OTHER

Conventional children book. No electronic device will be given to children.

Other: Non Augmented Reality

Interventions

Augmented Reality OTHER

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 (AR)

Non Augmented Reality OTHER

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.

Non Augmented Reality (NoAR)

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with adrenal diseases such as Cushing's or Addison Disease
• Patients with steroid prescription

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Hospital Cayetano Heredia

Lima, 15102, Peru

Location

Related Publications (8)

• 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.

  PMID: 23056788 BACKGROUND

• 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.

  PMID: 27483728 BACKGROUND

• 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.

  PMID: 23078405 BACKGROUND

• 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.

  PMID: 27114816 BACKGROUND

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

  PMID: 22559183 BACKGROUND

• 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.

  PMID: 26339283 BACKGROUND

• 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.

  PMID: 19171296 BACKGROUND

• Alarcon-Yaquetto DE, Tincopa JP, Guillen-Pinto D, Bailon N, Carcamo CP. Effect of augmented reality books in salivary cortisol levels in hospitalized pediatric patients: A randomized cross-over trial. Int J Med Inform. 2021 Apr;148:104404. doi: 10.1016/j.ijmedinf.2021.104404. Epub 2021 Feb 4.

  PMID: 33581476 DERIVED

Study Officials

• Dulce E. Alarcón-Yaquetto, BSc

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Cesar P Cárcamo, MD PhD

  Universidad Peruana Cayetano Heredia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: June 5, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 15, 2018
• Access Criteria: Open Access

Locations

PE (1)