Virtual Reality as a Self-Efficacy Intervention

Psychological Clinical Trial

Official title:

Improving Self-Efficacy of Hospitalized Children With Virtual Reality Education: A Pragmatic, Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725395
• Other study ID #: 68166
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Thomas J Caruso, MD, MEd
• Phone: 650-723-5728
• Email: tjcaruso[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

While virtual reality has gained momentum as a therapeutic supplement to distract from pain perception and to reduce anxiety, it has received less attention as an intervention to promote more holistic psychological self-efficacy in the course of in-patient care. Child and adolescent self-reported measures of self-efficacy have also been looked over in favor of parent or practitioner measures of a child's self-efficacy.

To evaluate the effectiveness of virtual reality on child and adolescent self-efficacy while undergoing hospital care, the investigators will determine the effect of virtual reality to 1) increase pediatric patient self-efficacy compared to standard of care using educational virtual reality, 2) establish a comprehensive profile of short-term psychological well-being in school-aged children and adolescents following admission to a hospital. Participants will serve as their own control to either receive intervention on the first day or second day of the in-patient care and no intervention will be given on the other day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• Patients' age range from 5 to 25 at LPCH/SHC facilities

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Psychological

Intervention

Behavioral:
• Virtual Reality
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
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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Caruso

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the Positive and Negative Affect feeling and emotion for Children	Measured with ten items from the Positive and Negative Affect Schedule for Children (PANAS-C). The positive affect (PA) and negative affect (NA) feelings and emotions are scored on scale ranging from 1 (Very slightly or not at all) to 5 (Extremely)	Day 1(baseline), Day 2
Primary	Change in educational self efficacy	Measured with six items from the modified New General Self-Efficacy Scale. The educational self efficacy is scored on scale ranging from 1 (strongly disagree) to 5 (strongly agree)	Day 1(baseline), Day 2
Secondary	Change in current mental well being as measured by the modified WHO (Five) Well-Being Index	The modified WHO (Five) Well-Being Index is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions . Scores range from 0 to 5, with higher scores indicating the corresponding feeling exists all the time.	Day 1(baseline), Day 2
Secondary	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	Change in the self-esteem (child)	Measured with five items from the modified Rosenberg Self-Esteem Scale (child). The self-esteem is scored on scale ranging from 1 (very true) to 4 (Definitely not true)	Day 1(baseline), Day 2
Secondary	Change in the self-esteem (Adolescent)	Measured with five items from the modified Rosenberg Self-Esteem Scale (Adolescent). The self-esteem is scored on scale ranging from 1 (Strongly agree) to 4 (Strongly disagree)	Day 1(baseline), Day 2
Secondary	Change in the caregiver perception of the educational experience of the patient	Measured with seven items from a modified Educational Experience Parental Survey Scale. The caregiver perception of the educational experience of the patient is scored on scale ranging from 1 (strongly disagree) to 7 (strongly agree)	Day 1(baseline), Day 2