AweNCT05743062
Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
A study testing Virtual Reality in people with Awe, run by Stanford University at 1 site in United States.
Trial summary
This is an experimental study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers (e.g., parents, guardians) Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Awe
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2023to 3 Aug 2023
- 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 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with age range from 6 to 25
- Adult or LAR with age range from 18 to 99
- Able to consent or have parental consent
- in pre-operative holding and inpatient acute care areas of LCPH
- English speaking participants
Who cannot join
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Visual Problems
- currently have nausea
- history of seizures
- non-english participants
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Parkard Children's Hospital
Stanford, California, 94304
About this study
This is an experimental study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers (e.g., parents, guardians)
Read the detailed description
Hospitalized pediatric patients, especially those undergoing anesthesia and surgery, experience anxiety and fear, resulting in lack of cooperation, withdrawal, and aggression. These reactions delay medical care and negatively impact patient experience.
This is an experimental, prospective study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers. The primary center for this study will be Lucile Packard Children's Hospital Stanford (LPCHS) (located within Stanford University, Palo Alto, CA).
After software development, we will evaluate the awe and engagement of pediatric patients after experiencing the novel virtual reality application.
- Conditions
- Awe
- Being tested
- Virtual Reality, Control
- Keywords
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. Participants will be asked to fill out a survey before the intervention to collect the baseline data, after each session of VR intervention and a final survey at the end of the study.
ControlOther
For case control, participants will service as their self control and no VR intervention will be given at first. Participants will be asked to fill out a survey before the intervention to collect the baseline data.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. Receives: Behavioral: Virtual Reality |
| Control | Other | Participants will serve as their own controls. Participants will not be given any VR intervention at first but they are requested to fill out the survey to collect the baseline data. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in awe levels measured by Global Perceived Awe Survey
Global Perceived Awe Survey contains an 7-point Likert scale . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Measured: Duration of intervention, approximately 20-30 minutes
Secondary outcomes (3)
Change in engagement measured by Game Engagement Questionnaire
Game Engagement Questionnaire contains 19 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Measured: Duration of intervention, approximately 20-30 minutes
Change in awe levels measured by Perceived Vastness Survey
Perceived Vastness Survey contains 4 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Measured: Duration of intervention, approximately 20-30 minutes
Change in awe levels measured by Perceived Need for Accommodation Survey
Perceived Need for Accommodation Survey contains 3 items . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
Measured: Duration of intervention, approximately 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start29 Jun 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AweStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743062
- Sponsor's protocol ID
- 69170
- Status last verified
- Jan 2024
- First submitted
- 14 Feb 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chirico A, Cipresso P, Yaden DB, Biassoni F, Riva G, Gaggioli A. Effectiveness of Immersive Videos in Inducing Awe: An Experimental Study. Sci Rep. 2017 Apr 27;7(1):1218. doi: 10.1038/s41598-017-01242-0.
PubMed 28450730Rodriguez CM, Clough V, Gowda AS, Tucker MC. Multimethod assessment of children's distress during noninvasive outpatient medical procedures: child and parent attitudes and factors. J Pediatr Psychol. 2012 Jun;37(5):557-66. doi: 10.1093/jpepsy/jss005. Epub 2012 Mar 16.
PubMed 22427698Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.
PubMed 28652955Chirico A, Ferrise F, Cordella L, Gaggioli A. Designing Awe in Virtual Reality: An Experimental Study. Front Psychol. 2018 Jan 22;8:2351. doi: 10.3389/fpsyg.2017.02351. eCollection 2017.
PubMed 29403409Caruso TJ, O'Connell C, Qian JJ, Kung T, Wang E, Kinnebrew S, Pearson M, Kist M, Menendez M, Rodriguez ST. Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. Pediatr Qual Saf. 2020 Apr 10;5(2):e293. doi: 10.1097/pq9.0000000000000293. eCollection 2020 Mar-Apr.
PubMed 32426648Richey AE, Hastings KG, Karius A, Segovia NA, Caruso TJ, Frick S, Rodriguez S. Virtual Reality Reduces Fear and Anxiety During Pediatric Orthopaedic Cast Room Procedures: A Randomized Controlled Trial. J Pediatr Orthop. 2022 Nov-Dec 01;42(10):600-607. doi: 10.1097/BPO.0000000000002250. Epub 2022 Aug 30.
PubMed 36040069Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Paediatr Anaesth. 2022 Dec;32(12):1292-1304. doi: 10.1111/pan.14546. Epub 2022 Sep 1.
PubMed 35993398Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
PubMed 31136330Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
PubMed 36330583
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
- ClinicalTrials.gov ID
- NCT05743062
- Acronym / sponsor ID
- 69170
- Conditions
- Awe
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 24 Feb 2023 (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.
This is an experimental study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers (e.g., parents, guardians)
Detailed description
Hospitalized pediatric patients, especially those undergoing anesthesia and surgery, experience anxiety and fear, resulting in lack of cooperation, withdrawal, and aggression. These reactions delay medical care and negatively impact patient experience.
This is an experimental, prospective study to evaluate which aspects of virtual reality (VR) software development can be optimized to increase awe in pediatric perioperative patients and their adult caregivers. The primary center for this study will be Lucile Packard Children's Hospital Stanford (LPCHS) (located within Stanford University, Palo Alto, CA).
After software development, we will evaluate the awe and engagement of pediatric patients after experiencing the novel virtual reality application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual RealityVirtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. |
| Control | Other | Other: ControlParticipants will serve as their own controls. Participants will not be given any VR intervention at first but they are requested to fill out the survey to collect the baseline data. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with age range from 6 to 25
- Adult or LAR with age range from 18 to 99
- Able to consent or have parental consent
- in pre-operative holding and inpatient acute care areas of LCPH
- English speaking participants
Key exclusion criteria (7 listed)
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Visual Problems
- currently have nausea
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 |
|---|---|---|
| Virtual RealityVirtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. Participants will be asked to fill out a survey before the intervention to collect the baseline data, after each session of VR intervention and a final survey at the end of the study. | Behavioural | Virtual Reality |
| ControlFor case control, participants will service as their self control and no VR intervention will be given at first. Participants will be asked to fill out a survey before the intervention to collect the baseline data. | Other | Control |
Primary outcome
Change in awe levels measured by Global Perceived Awe Survey
Time frame: Duration of intervention, approximately 20-30 minutes
Global Perceived Awe Survey contains an 7-point Likert scale . Scores range from 1 (strongly disagree) to 7 (Strongly agree), with higher score indicates strongly agree to the statement.
3 secondary outcomes
Change in engagement measured by Game Engagement Questionnaire
Time frame: Duration of intervention, approximately 20-30 minutes
Change in awe levels measured by Perceived Vastness Survey
Time frame: Duration of intervention, approximately 20-30 minutes
Change in awe levels measured by Perceived Need for Accommodation Survey
Time frame: Duration of intervention, approximately 20-30 minutes
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 31 Jan 2024.
- Background: PubMed 28450730Chirico A, Cipresso P, Yaden DB, Biassoni F, Riva G, Gaggioli A. Effectiveness of Immersive Videos in Inducing Awe: An Experimental Study. Sci Rep. 2017 Apr 27;7(1):1218. doi: 10.1038/s41598-017-01242-0.
- Background: PubMed 22427698Rodriguez CM, Clough V, Gowda AS, Tucker MC. Multimethod assessment of children's distress during noninvasive outpatient medical procedures: child and parent attitudes and factors. J Pediatr Psychol. 2012 Jun;37(5):557-66. doi: 10.1093/jpepsy/jss005. Epub 2012 Mar 16.
- Background: PubMed 28652955Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.
- Background: PubMed 29403409Chirico A, Ferrise F, Cordella L, Gaggioli A. Designing Awe in Virtual Reality: An Experimental Study. Front Psychol. 2018 Jan 22;8:2351. doi: 10.3389/fpsyg.2017.02351. eCollection 2017.
- Background: PubMed 32426648Caruso TJ, O'Connell C, Qian JJ, Kung T, Wang E, Kinnebrew S, Pearson M, Kist M, Menendez M, Rodriguez ST. Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. Pediatr Qual Saf. 2020 Apr 10;5(2):e293. doi: 10.1097/pq9.0000000000000293. eCollection 2020 Mar-Apr.
- Background: PubMed 36040069Richey AE, Hastings KG, Karius A, Segovia NA, Caruso TJ, Frick S, Rodriguez S. Virtual Reality Reduces Fear and Anxiety During Pediatric Orthopaedic Cast Room Procedures: A Randomized Controlled Trial. J Pediatr Orthop. 2022 Nov-Dec 01;42(10):600-607. doi: 10.1097/BPO.0000000000002250. Epub 2022 Aug 30.
- Background: PubMed 35993398Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Paediatr Anaesth. 2022 Dec;32(12):1292-1304. doi: 10.1111/pan.14546. Epub 2022 Sep 1.
- Background: PubMed 31136330Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
- Background: PubMed 36330583Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
- The development of the Game Engagement Questionnaire: A measure of engagement in video game-playing.Link provided by the sponsor.
- The development of the Awe Experience Scale (AWE-S): A multifactorial measure for a complex emotionLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Awe, run by Stanford University at 1 site in United States.
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 7 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 31 Jan 2024. 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 United States. 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 awe levels measured by Global Perceived Awe Survey (time frame: Duration of intervention, approximately 20-30 minutes). 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 NCT05743062, which also lists 9 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 31 Jan 2024.