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VR to Reduce Pain and Anxiety During GU Scans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251988
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
National Association of Theater Owners
Information provided by (Responsible Party):
Andy Y. Chang, Children's Hospital Los Angeles

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 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.

Condition or disease Intervention/treatment Phase
Urologic Diseases Urogenital Disease Vesico-Ureteral Reflux Device: Oculus Go VR Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Virtual Reality (VR) to Reduce Pain and Anxiety During Genitourinary (GU) Scans
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Change in Pain during VCUG - Faces Pain Scale-Revised [ Time Frame: Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG. ]
    Participant levels of pain will be assessed using the Faces Pain Scale-Revised (min. score = 0; max. score = 10. Higher score = higher pain)

  2. Change in Pain during VCUG - Colored Analog Scale [ Time Frame: Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG. ]
    Participant levels of pain will be assessed using the Colored Analog Scale (min. score = 0; max. score = 10. Higher score = higher pain)

  3. Change in Anxiety during VCUG - Procedural Anxiety Visual Analog Scale [ Time Frame: Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG. ]
    Participant levels of anxiety will be assessed using the Procedural Anxiety Visual Analog Scale (min. score = 0; max. score = 10. Higher score = higher anxiety)

  4. Change in Anxiety during VCUG - Facial Affective Scale [ Time Frame: Will be administered to participants approximately 20 minutes before the start of the VCUG, and within 15 minutes following the end of the VCUG. ]
    Participant levels of anxiety will be assessed using the Facial Affective Scale (min. score = 0; max. score = 1. Higher score = higher anxiety)

  5. Baseline Anxiety before VCUG - Anxiety Sensitivity Index [ Time Frame: Will be administered to participants approximately 20 minutes before the start of the VCUG. ]
    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).

  6. Satisfaction with VR [ Time Frame: Questionnaires will be administered to participants within 15 minutes following the end of the VCUG. ]
    Participant satisfaction with VR assessed using a 10-item satisfaction survey (min. score = 0; max. score = 50. Higher score = higher satisfaction).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for children:

  1. Children who are 5-21 years old
  2. Children who are English or Spanish speaking.
  3. Children undergoing a VCUG at CHLA.
  4. 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):

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

Inclusion criteria for healthcare providers (no age limits):

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

Exclusion Criteria:

  1. Child is currently taking pain medication or anxiolytic medication, including midazolam
  2. 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
  3. Child has visual, auditory, or tactile deficit that would interfere with the ability to complete the experimental tasks
  4. Child has a history of seizure disorder
  5. Child is currently sick with flu-like symptoms or experiencing a headache or earache
  6. Child has known or suspected motion sickness
  7. Child catheterizes regularly or has an insensate urethra
  8. Languages other than English and Spanish will be excluded given that the proposed measures have not been standardized for use in other languages.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251988


Contacts
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Contact: Zoe Baker, MPH, PhD 323-361-5573 zobaker@chla.usc.edu
Contact: Erin Annick, BA 323-361-6244 ext 16244 eannick@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Contact: Zoe Baker, MPH, PhD    323-361-5573    zobaker@chla.usc.edu   
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Zoë G Baker, PhD    323-361-5573    zobaker@chla.usc.edu   
Contact: Erin Annick, BA       eannick@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
National Association of Theater Owners
Publications:
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Responsible Party: Andy Y. Chang, Attending Physician; Vice Chief, Division of Pediatric Urology, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04251988    
Other Study ID Numbers: ChildrenHLA-19-00403
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Andy Y. Chang, Children's Hospital Los Angeles:
virtual reality, voiding cystourethrogram, catheterization
Additional relevant MeSH terms:
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Urologic Diseases
Vesico-Ureteral Reflux
Urinary Bladder Diseases