Urologic DiseasesNCT04251988
VR to Reduce Pain and Anxiety During GU Scans
A study testing Oculus Go VR in people with Urologic Diseases and Urogenital Disease, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases, Urogenital Disease, Vesico-Ureteral Reflux
- What is being tested?
- Oculus Go VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: 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.
Read the 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
- Being tested
- Oculus Go VR
- Keywords
- virtual reality, voiding cystourethrogram, catheterization
- Medical subject headings
- Urologic Diseases, Urogenital Diseases, Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus Go VRDevice
virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oculus Go VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Participant levels of pain will be assessed using the Faces Pain Scale-Revised (min. score = 0; max. score = 10. Higher score = higher pain)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Questionnaires will be administered to participants within 15 minutes following the end of the VCUG.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Feb 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andy Y. Chang, Children's Hospital Los Angeles
- Investigators
- Andy M Chang, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251988
- Sponsor's protocol ID
- CHLA-19-00403
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.
PubMed 22763832Guideline 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.
PubMed 27931463Glazer 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.
PubMed 3810213Stashinko 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.
PubMed 10196917
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality (VR) to Reduce Pain and Anxiety During Genitourinary (GU) Scans
- ClinicalTrials.gov ID
- NCT04251988
- Acronym / sponsor ID
- CHLA-19-00403
- Keywords
- virtual reality, voiding cystourethrogram, catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Oculus Go VRPatients will receive virtual reality in addition to standard of care. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus Go VRvirtual reality headset | Device | VR Randomization |
Primary outcome
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)
6 secondary outcomes
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.
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.
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.
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.
Baseline Anxiety before VCUG - Anxiety Sensitivity Index
Time frame: Will be administered to participants approximately 20 minutes before the start of the VCUG.
Satisfaction with VR
Time frame: Questionnaires will be administered to participants within 15 minutes following the end of the VCUG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 22763832Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.
- Background: PubMed 27931463Guideline 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.
- Background: PubMed 3810213Glazer 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.
- Background: PubMed 10196917Stashinko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy M Chang, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus Go VR in people with Urologic Diseases and Urogenital Disease, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251988, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.