VR to Reduce Pain and Anxiety During GU Scans

The Effectiveness of Virtual Reality (VR) to Reduce Pain and Anxiety During Genitourinary (GU) Scans

This study aims to test the effectiveness of virtual reality (VR) in reducing pain and anxiety in children undergoing voiding cystourethrograms (VCUG) at Children's Hospital Los Angeles (CHLA). A voiding cystourethrogram is a genitourinary diagnostic scan that provides important urological information, specifically the filling and releasing of the bladder. This information can help diagnose urological issues in children. However, this procedure requires catheterization, which is understood to be a painful and anxiety-provoking procedure. This study will test the effectiveness of VR as a non-pharmaceutical intervention to relieve pain and anxiety in pediatric patients undergoing VCUGs.

Study Overview

• Status: Active, not recruiting
• Conditions: Urologic Diseases; Urogenital Disease; Vesico-Ureteral Reflux
• Intervention / Treatment: Device: Oculus Go VR

Detailed Description

Background: VCUGs are genitourinary diagnostic scans that provide valuable medical information for pediatric patients with urological issues. However, these scans require catheterization, which can be anxiety-provoking, painful, and in some cases traumatic. Previous studies have assessed the use of pharmacological agents to address pain and anxiety during these procedures, but few studies exist examining non-pharmacological interventions in a methodologically rigorous way. As pharmacological interventions are associated with numerous side effects, and may not be appropriate for all pediatric patients, effective non-pharmacological interventions are needed for patients undergoing VCUGs.

Aims: This study aims to determine the effectiveness of virtual reality (VR) in reducing pain and anxiety among children undergoing VCUGs at CHLA. This study will also assess patient, parent, and provider satisfaction with VR, and ease of completing VCUGs using VR vs. the standard of care.

Study Population: CHLA patients aged 5-21 years receiving VCUGs at CHLA. Methods: A stratified randomization scheme will be used to assign patients aged 5-21 undergoing VCUG scans to receive the standard of care (i.e. caregiver presence in the room and Child Life Specialists in the room if desired), or the standard of care plus VR. Individuals assigned to the VR arm will be fitted with a Samsung head-tracking system, and will play an AppliedVR game prior to and during catheterization. Standardized questionnaires will be administered to patients and caregivers before and after the procedure to measure pain and anxiety. Satisfaction questionnaires will be administered post-procedure.

Significance: VR is a non-invasive intervention that, if effective, could become part of a standard protocol to reduce pain and anxiety among children undergoing VCUGs. As there is a dearth of knowledge regarding non-pharmacologic interventions for children receiving VCUGs, this study will provide a foundation to inform future research on VR use among pediatric urology patients.

See 'References' for Brief Summary References

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zoe Baker, MPH, PhD; Phone Number: 323-361-5573; Email: zobaker@chla.usc.edu
• Study Contact Backup: Name: Erin Annick, BA; Phone Number: 16244 323-361-6244; Email: eannick@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for children:

• Children who are 5-21 years old
• Children who are English or Spanish speaking.
• Children undergoing a VCUG at CHLA.
• Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of medical procedures differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

Inclusion criteria for caregivers (no age limits):

• Have a child who is undergoing a VCUG at CHLA.
• Caregiver is present during the child's VCUG.
• Caregiver is English or Spanish speaking.
• Caregiver is 18 years old or older.

Inclusion criteria for healthcare providers (no age limits):

• Provider is 18 years old or older
• Provider is a CHLA employee.
• Provider may participate if he/she witnessed and/or administered the medical procedure.

Exclusion Criteria:

• Child is currently taking pain medication or anxiolytic medication, including midazolam
• Child has a psychiatric disorder (i.e. anxiety, psychotic, thought disorder), organic brain syndrome, intellectual disability, Autism Spectrum Disorder, or other known cognitive/neurological disorder
• Child has visual, auditory, or tactile deficit that would interfere with the ability to complete the experimental tasks
• Child has a history of seizure disorder
• Child is currently sick with flu-like symptoms or experiencing a headache or earache
• Child has known or suspected motion sickness
• Child catheterizes regularly or has an insensate urethra
• Languages other than English and Spanish will be excluded given that the proposed measures have not been standardized for use in other languages.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care (No VR) Randomization; Patients will receive standard of care during catheterization, which includes caregiver presence in the room and Child Life Specialists in the room, if desired, and does not include virtual reality.
Experimental: VR Randomization; Patients will receive virtual reality in addition to standard of care.	Device: Oculus Go VR; virtual reality headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain during VCUG - Pain Visual Analog Scale	Participant levels of pain will be assessed using the Pain Visual Analog Scale (min. score = 0; max. score = 100. Higher score = higher pain)	Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain during VCUG - Faces Pain Scale-Revised	Participant levels of pain will be assessed using the Faces Pain Scale-Revised (min. score = 0; max. score = 10. Higher score = higher pain)	Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG.
Change in Pain during VCUG - Colored Analog Scale	Participant levels of pain will be assessed using the Colored Analog Scale (min. score = 0; max. score = 10. Higher score = higher pain)	Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG.
Change in Anxiety during VCUG - Procedural Anxiety Visual Analog Scale	Participant levels of anxiety will be assessed using the Procedural Anxiety Visual Analog Scale (min. score = 0; max. score = 10. Higher score = higher anxiety)	Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG.
Change in Anxiety during VCUG - Facial Affective Scale	Participant levels of anxiety will be assessed using the Facial Affective Scale (min. score = 0; max. score = 1. Higher score = higher anxiety)	Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG.
Baseline Anxiety before VCUG - Anxiety Sensitivity Index	Participant baseline anxiety will be assessed using the Anxiety Sensitivity Index, a 16-item questionnaire (min. score = 0; max. score = 64. Higher score = higher anxiety sensitivity; i.e. higher dispositional tendency to fear the somatic and cognitive symptoms of anxiety due to a belief that these symptoms may be dangerous or harmful).	Will be administered to participants approximately 20 minutes before the start of the VCUG.
Satisfaction with VR	Participant satisfaction with VR assessed using a 10-item satisfaction survey (min. score = 0; max. score = 50. Higher score = higher satisfaction).	Questionnaires will be administered to participants within 15 minutes following the end of the VCUG.

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: National Association of Theater Owners
• Investigators: Principal Investigator: Andy M Chang, MD, Children's Hospital Los Angeles

Publications and helpful links

General Publications

• Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.
• Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatr Dent. 2016 Oct;38(6):216-245.
• Glazer JD, Benrubi GI, Nuss RC. Positive results of endocervical curettage as an indication for conization of the cervix. South Med J. 1987 Feb;80(2):185-6. doi: 10.1097/00007611-198702000-00011.
• Stashinko EE, Goldberger J. Test or trauma? The voiding cystourethrogram experience of young children. Issues Compr Pediatr Nurs. 1998 Apr-Jun;21(2):85-96. doi: 10.1080/014608698265519.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality, voiding cystourethrogram, catheterization
• Additional Relevant MeSH Terms: Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Urologic Diseases; Vesico-Ureteral Reflux; Urogenital Diseases
• Other Study ID Numbers: CHLA-19-00403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No