NCT05725395

Brief Summary

The goal is to explore the use of Virtual Reality (VR) as an intervention to increase intrinsic motivation in a healthcare setting. The investigators would like to determine if an educational VR intervention in the course of healthcare could increase pediatric patient intrinsic motivation compared to standard of care (i.e no VR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

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

November 22, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

November 4, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

November 22, 2022

Last Update Submit

October 31, 2025

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • Change in the intrinsic motivation

    Measured with six items from the modified Intrinsic Motivation Inventory (IMI) - Interest/Enjoyment Subscale. The perceived interest/enjoyment is scored on scale ranging from 1 (Not at all true) to 7 (very true)

    Day 1(baseline), Day 2

Secondary Outcomes (5)

  • Change in current mental well being as measured by the modified WHO (Five) Well-Being Index

    Day 1(baseline), Day 2

  • Change in the self-esteem (child)

    Day 1(baseline), Day 2

  • Change in the self-esteem (Adolescent)

    Day 1(baseline), Day 2

  • Change in the caregiver perception of the educational experience of the patient

    Day 1(baseline), Day 2

  • Change in educational self efficacy

    Day 1(baseline), Day 2

Other Outcomes (1)

  • Change in the Positive and Negative Affect feeling and emotion for Children

    Day 1(baseline), Day 2

Study Arms (2)

Virtual Reality then Standard of Care

EXPERIMENTAL

Participants will be randomized to receive the virtual reality intervention on the first day and receive standard of care on the second day of in-patient care.

Behavioral: Virtual RealityBehavioral: Standard of Care

Standard of Care then Virtual Reality

EXPERIMENTAL

Participants will be randomized to receive the standard of care on the first day and receive virtual reality intervention on the second day of in-patient care.

Behavioral: Virtual RealityBehavioral: Standard of Care

Interventions

Virtual RealityBEHAVIORAL

During in-patient care participants will be randomized to receive or not receive the educational virtual reality intervention on the first day. After two days, participants will receive a total of 10 minutes interventional in the morning (between 8am to 12pm) every day until their in-patient care concludes.

Standard of Care then Virtual RealityVirtual Reality then Standard of Care

For case control, participants will service as their self control and be randomized to receive no virtual reality intervention on either the first day or the second day of in-patient care.

Standard of Care then Virtual RealityVirtual Reality then Standard of Care

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients' age range from 5 to 25 at LPCH/SHC facilities
  • patient who speak english only

You may not qualify if:

  • Participants who do not consent
  • Have a history of seizure disorder
  • Currently have nausea
  • Have motion sickness
  • Are clinically unstable
  • Currently using corrective glasses (not compatible with VR headset)
  • Currently pregnant
  • non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (8)

  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND
  • Kern ML, Benson L, Steinberg EA, Steinberg L. The EPOCH Measure of Adolescent Well-Being. Psychol Assess. 2016 May;28(5):586-97. doi: 10.1037/pas0000201. Epub 2015 Aug 24.

    PMID: 26302102BACKGROUND
  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PMID: 18696313BACKGROUND
  • Duckworth AL, Peterson C, Matthews MD, Kelly DR. Grit: perseverance and passion for long-term goals. J Pers Soc Psychol. 2007 Jun;92(6):1087-101. doi: 10.1037/0022-3514.92.6.1087.

    PMID: 17547490BACKGROUND
  • Duckworth AL, Quinn PD. Development and validation of the short grit scale (grit-s). J Pers Assess. 2009 Mar;91(2):166-74. doi: 10.1080/00223890802634290.

    PMID: 19205937BACKGROUND
  • Rosenberg M. [Consciousness from the viewpoint of electrophysics]. Psychiatr Neurol Med Psychol (Leipz). 1965 Nov;17(11):408-10. No abstract available. German.

    PMID: 5884740BACKGROUND
  • Lachman ME, Weaver SL. The sense of control as a moderator of social class differences in health and well-being. J Pers Soc Psychol. 1998 Mar;74(3):763-73. doi: 10.1037//0022-3514.74.3.763.

    PMID: 9523418BACKGROUND
  • Kallem S, Carroll-Scott A, Rosenthal L, Chen E, Peters SM, McCaslin C, Ickovics JR. Shift-and-persist: a protective factor for elevated BMI among low-socioeconomic-status children. Obesity (Silver Spring). 2013 Sep;21(9):1759-63. doi: 10.1002/oby.20195. Epub 2013 May 13.

    PMID: 23671041BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 22, 2022

First Posted

February 13, 2023

Study Start

June 20, 2023

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

November 4, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations