NCT04251988

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

January 23, 2020

Last Update Submit

June 13, 2023

Conditions

Urologic DiseasesUrogenital DiseaseVesico-Ureteral Reflux

Keywords

virtual reality, voiding cystourethrogram, catheterization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Pain during VCUG - Faces Pain Scale-Revised

    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

    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

    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

    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

    Will be administered to participants approximately 20 minutes before the start of the VCUG.

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care (No VR) Randomization

NO INTERVENTION

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.

VR Randomization

EXPERIMENTAL

Patients will receive virtual reality in addition to standard of care.

Device: Oculus Go VR

Interventions

Oculus Go VRDEVICE

virtual reality headset

VR Randomization

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (4)

  • Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.

    PMID: 22763832BACKGROUND

  • 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.

    PMID: 27931463BACKGROUND

  • 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.

    PMID: 3810213BACKGROUND

  • 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.

    PMID: 10196917BACKGROUND

MeSH Terms

Conditions

Urologic DiseasesUrogenital DiseasesVesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesUrinary Bladder Diseases

Study Officials

  • Andy M Chang, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician; Vice Chief, Division of Pediatric Urology

Study Record Dates

First Submitted

January 23, 2020

First Posted

February 5, 2020

Study Start

February 15, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)