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

NCT ID: NCT05743062

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-29

Study Completion Date

2023-08-03

Brief Summary

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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

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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

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Awe

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Virtual Reality

Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type OTHER

Control

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Caruso

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucile Parkard Children's Hospital

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28450730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22427698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28652955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29403409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32426648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36040069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35993398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31136330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36330583 (View on PubMed)

Related Links

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https://www.semanticscholar.org/paper/EFFECT-OF-OPERATIVE-PROCEDURES-ON-THE-EMOTIONAL-OF-Pearson/3cd20d7f33c26882edb7a4df4650b81f495702a3

The development of the Game Engagement Questionnaire: A measure of engagement in video game-playing.

Other Identifiers

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69170

Identifier Type: -

Identifier Source: org_study_id

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