Clinical trial NCT05743062: Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
Official title: Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Awe
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 202
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Visual Problems
* currently have nausea
* history of seizures
* non-english participants

Primary outcomes:
measure: Change in awe levels measured by Global Perceived Awe Survey
timeFrame: Duration of intervention, approximately 20-30 minutes
Secondary outcomes:
measure: Change in engagement measured by Game Engagement Questionnaire
timeFrame: Duration of intervention, approximately 20-30 minutes
measure: Change in awe levels measured by Perceived Vastness Survey
timeFrame: Duration of intervention, approximately 20-30 minutes
measure: Change in awe levels measured by Perceived Need for Accommodation Survey
timeFrame: Duration of intervention, approximately 20-30 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Parkard Children's Hospital
state: California
Study officials:
References:
citation: 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.
citation: Rodriguez 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.
citation: Chon T, Ma A, Mun-Price C. Perioperative Fasting and the Patient Experience. Cureus. 2017 May 24;9(5):e1272. doi: 10.7759/cureus.1272.
citation: Chirico 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.
citation: Caruso 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.
citation: Richey 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.
citation: Tas 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.
citation: Eijlers 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.
citation: Gao 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.