NCT05743062

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

February 14, 2023

Last Update Submit

January 29, 2024

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in engagement measured by Game Engagement Questionnaire

    Duration of intervention, approximately 20-30 minutes

  • Change in awe levels measured by Perceived Vastness Survey

    Duration of intervention, approximately 20-30 minutes

  • Change in awe levels measured by Perceived Need for Accommodation Survey

    Duration of intervention, approximately 20-30 minutes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

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.

Other: Control

Interventions

Virtual RealityBEHAVIORAL

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.

Virtual Reality
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.

Control

Eligibility Criteria

Age6 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Location

Related Publications (9)

  • 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.

    PMID: 28450730BACKGROUND
  • 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.

    PMID: 22427698BACKGROUND
  • 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.

    PMID: 28652955BACKGROUND
  • 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.

    PMID: 29403409BACKGROUND
  • 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.

    PMID: 32426648BACKGROUND
  • 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.

    PMID: 36040069BACKGROUND
  • 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.

    PMID: 35993398BACKGROUND
  • 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.

    PMID: 31136330BACKGROUND
  • 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.

    PMID: 36330583BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 24, 2023

Study Start

June 29, 2023

Primary Completion

August 3, 2023

Study Completion

August 3, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations