Hospitalized ChildNCT03537859
Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients
A study testing Augmented Reality and Non Augmented Reality in people with Hospitalized Child, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Hospitalized Child
- What is being tested?
- Augmented Reality and Non Augmented Reality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePeru
- Study dates
- 5 Jun 2018to 18 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with adrenal diseases such as Cushing's or Addison Disease
- Patients with steroid prescription
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.
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.
Read the 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.
- Conditions
- Hospitalized Child
- Being tested
- Augmented Reality, Non Augmented Reality
- Keywords
- hospitalized child, salivary cortisol, augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
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 RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality (AR) | Experimental | Books with augmented reality plus an electronic tablet. Receives: Other: Augmented Reality |
| Non Augmented Reality (NoAR) | Other | Conventional children book. No electronic device will be given to children. Receives: Other: Non Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary cortisol levels
Cortisol of salivary samples will be analyzed with a commercial Enzyme Immune Assay kit (DRG , Germany).
Measured: 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)
A pictograph scale, caricatures of children with different mood going from 1 (crying) to 5 (very happy) given to children to self - assess mood.
Measured: VAS will be given immediately after salivary collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start5 Jun 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hospitalized ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dulce E. Alarcón-Yaquetto, BSc, Principal investigator, Universidad Peruana Cayetano HerediaCesar P Cárcamo, MD PhD, Study director, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537859
- Sponsor's protocol ID
- SIDISI 101432
- Other IDs
- 036-018
- Status last verified
- May 2019
- First submitted
- 15 May 2018
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
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.
PubMed 23056788Mindru 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.
PubMed 27483728Potasz 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.
PubMed 23078405Saliba 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.
PubMed 27114816Berryman DR. Augmented reality: a review. Med Ref Serv Q. 2012;31(2):212-8. doi: 10.1080/02763869.2012.670604.
PubMed 22559183Chicchi 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.
PubMed 26339283McCarthy 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.
PubMed 19171296Alarcon-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.
PubMed 33581476
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Augmented Reality Books on Cortisol Levels in Hospitalized Pediatric Patients: a Cross-over Study.
- ClinicalTrials.gov ID
- NCT03537859
- Acronym / sponsor ID
- SIDISI 101432
- Conditions
- Hospitalized Child
- Keywords
- hospitalized child, salivary cortisol, augmented reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality (AR) | Experimental | Other: Augmented RealityBooks with augmented reality plus an electronic tablet. |
| Non Augmented Reality (NoAR) | Other | Other: Non Augmented RealityConventional children book. No electronic device will be given to children. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with adrenal diseases such as Cushing's or Addison Disease
- Patients with steroid prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityAugmented 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 | Augmented Reality (AR) |
| Non Augmented RealityAugmented 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. | Other | Non Augmented Reality (NoAR) |
Primary outcome
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).
1 secondary outcome
Visual analogue scale (VAS)
Time frame: VAS will be given immediately after salivary collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Background: PubMed 23056788Bsiri-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.
- Background: PubMed 27483728Mindru 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.
- Background: PubMed 23078405Potasz 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.
- Background: PubMed 27114816Saliba 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.
- Background: PubMed 22559183Berryman DR. Augmented reality: a review. Med Ref Serv Q. 2012;31(2):212-8. doi: 10.1080/02763869.2012.670604.
- Background: PubMed 26339283Chicchi 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.
- Background: PubMed 19171296McCarthy 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.
- Derived from this study: PubMed 33581476Alarcon-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.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dulce E. Alarcón-Yaquetto, BSc principal investigator
Universidad Peruana Cayetano Heredia
Cesar P Cárcamo, MD PhD study director
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality and Non Augmented Reality in people with Hospitalized Child, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03537859, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.