VR to Reduce Pain and Anxiety During GU Scans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VR to Reduce Pain/Anxiety During Painful Procedures

NCT04268901

Phlebotomy Orthopedics Radiology +5 more

RECRUITING NA

VR for Lac Repairs in Peds Emergency Department

NCT06516003

Laceration

COMPLETED NA

How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department

NCT03692377

Child, Preschool

UNKNOWN

The Effect of Virtual Reality During Urodynamics on Vital Signs, Anxiety, and Satisfaction

NCT07277894

Urinary Incontinence Urodynamic Studies Urodynamics

NOT_YET_RECRUITING NA

Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

NCT06079814

Pain Anxiety

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urologic Diseases Urogenital Disease Vesico-Ureteral Reflux

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

VR Randomization

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

Group Type EXPERIMENTAL

Oculus Go VR

Intervention Type DEVICE

virtual reality headset

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oculus Go VR

virtual reality headset

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes