VR to Reduce Pain and Anxiety During GU Scans

Children's Hospital Los Angeles

Status: Active, not recruiting

Conditions: Vesico-Ureteral Reflux; Urogenital Disease; Urologic Diseases

Treatments: Device: Oculus Go VR

Study type: Interventional

Funder types: Other

Identifiers

NCT04251988

CHLA-19-00403

Details and patient eligibility

About

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.

Full 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

Enrollment: 410 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

410 participants in 2 patient groups

Standard of Care (No VR) Randomization

No Intervention group

Description:

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 group

Description:

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

Treatment:

Device: Oculus Go VR