NCT03537859|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Hospital Cayetano Heredia
interventional
29
1 country
1
Study Start
June 5, 2018
Actual (reported)Primary Completion
January 18, 2019
Actual (reported)Study Completion
January 18, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 18, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2018
Actual (reported)May 25, 2018
Actual (reported)June 5, 2018
Actual (reported)January 18, 2019
Actual (reported)January 18, 2019
Actual (reported)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.
Visual analogue scale (VAS)
VAS will be given immediately after salivary collection.
Books with augmented reality plus an electronic tablet.
Conventional children book. No electronic device will be given to children.
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.
Hospital Cayetano Heredia
Lima, 15102, Peru
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.
Dulce E. Alarcón-Yaquetto, BSc
Universidad Peruana Cayetano Heredia
Cesar P Cárcamo, MD PhD
Universidad Peruana Cayetano Heredia
29 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
June 5, 2018
Impact of Therapeutic Storytelling on Fear, Screen Time, and Parental Stress Among Hospitalized Children
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
January 18, 2019
Actual (reported)Study Completion
January 18, 2019
Actual (reported)Last Updated
May 8, 2019
Record last verified: 2019-05
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)
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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