Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children

Awe Clinical Trial

Official title:

Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743062
• Other study ID #: 69170
• Status: Completed
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: August 3, 2023

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Awe

Intervention

Behavioral:
• Virtual Reality
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.

Other:
• Control
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.

Locations

Country	Name	City	State
United States	Lucile Parkard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of intervention, approximately 20-30 minutes
Secondary	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.	Duration of intervention, approximately 20-30 minutes
Secondary	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.	Duration of intervention, approximately 20-30 minutes
Secondary	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.	Duration of intervention, approximately 20-30 minutes

External Links

•   EFFECT OF OPERATIVE PROCEDURES ON THE EMOTIONAL LIFE OF THE CHILD
•   The development of the Awe Experience Scale (AWE-S): A multifactorial measure for a complex emotion
•   The development of the Game Engagement Questionnaire: A measure of engagement in video game-playing.