AnxietyVPRONCT03784352
Virtual Reality Pediatric Orthopaedic Outpatient Procedures
A study testing Virtual Reality in people with Anxiety and Pain, run by British Columbia Children's Hospital at 1 site in Canada.
Trial summary
The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2019to 17 May 2019
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- child must be between the ages of 4 and 18 years
- the parent/guardians and child are both able to speak and read English or have a translator be present for them
Who cannot join
- symptoms of respiratory or gastrointestinal infection
- visual, auditory, cognitive impairment or developmental delay
- history of seizures or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial
The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections.
Read the detailed description
Immediately following recruitment, demographic data and diseased related information (ie. location of cast/hardware, reason for cast/hardware placement and location and reason for botox injection) will be collected through self and/or guardian report. All data will be collected using REDCap (research electronic data capture). Using a parallel group design, patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure classifications (hardware or cast or staple or suture removal or cast application or botox injection) site of hardware or cast or staple or suture or botox injection), and reason for the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI) is completed by the patient to collect pre-procedural state anxiety measurements. Following this, patients in the control group will receive standard of care (SOC) which allows for the technician and/or accompanying guardian to try and distract and or console the patient as they normally would. The patients in the intervention group will receive SOC with Virtual Reality (VR) interaction a few minutes before, during and following the procedure (around 5-10minutes total). During the procedure the researcher will complete an observational survey (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure and their current pain levels post procedure while parent/guardians and cast technician will be asked to complete their respective satisfaction questionnaires. Following this, the child will be asked if they experienced any nausea at any point during the procedure, if they did, they will be asked to complete the BARF questionnaire to measure the amount of nausea experienced. Following completion of questionnaires, patients who were in the control group are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to incentivize recruitment for the study.
SOC will consist of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure.
- Being tested
- Virtual Reality
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
A calming virtual reality game will be played
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Experimental | The intervention will consist of standard of care (SOC) in addition to the use of virtual reality. SOC consists of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) Patients assigned to the VR group will interact with VR through mobile-based VR googles. Receives: Device: Virtual Reality |
| No Virtual Reality (VR) | No intervention | This arm will receive regular standard of care (SOC), the same that would be received if they were not enrolled in the study. SOC will include the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong Baker Scale (WBS) for Procedural Pain
The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of "no pain" and "worst possible pain". There are six possible faces with "no pain" representing a score of 0 and "worst pain" representing a score of 10
Measured: Immediately post procedure
Anxiety (state anxiety intraprocedure)
Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include:
Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.
Measured: Intraprocedure
Secondary outcomes (5)
Procedural Time
Measured with a stopwatch: Start of the procedure defined as the moment the patient completes the first short SAIS, which is shortly upon entering the procedural room. End of the procedure is marked as follows: complete removal of cast (for cast removal), removal of last staple or hardware (staple and hardware removal), removal of needle from final injection site (botox injection)
Measured: Intraprocedure
Baxter Retching Faces (BARF) Scale for Nausea
Patients will use the pictorial Baxter Retching Faces Scale (BARF) to measure nausea severity. It is a scale of 0-10 with 6 faces, with the first representing no nausea to the last as experiencing vomiting. This scale has been shown to have construct, content and convergent validity in measuring nausea in children. After the patients have completed the post procedure short SAIS the patients will be asked if they had experienced any feelings of nausea at any point during the procedure. If they answer yes, then they will be asked to rate the nausea using the BARF scale.
Measured: Immediately post procedure
State Anxiety Preprocedure
State Anxiety will be measured prior to start of procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.
Measured: Immediately pre-procedure
State Anxiety Postprocedure
State Anxiety will also be measured immediately after completion of the procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes.
Measured: Immediately post procedure
Trait Anxiety
The Penn State Worry Questionnaire for Children (PSWQ-C) is a screening tool for assessing generalized anxiety in children aged 7-17 years. It consists of a 14 item self-reported questionnaire. Respondents indicate how often each item applies to them, choosing from the following responses: "never", "sometimes", "often", and "always", with points ranging from 0 to 3 for each item. The total score ranges from 0 to 42, with higher scores indicating a greater tendency to worry. The total time to complete the questionnaire is approximately five minutes.
Measured: Preprocedure while in the waiting area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start5 Feb 2019
- Primary completion10 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bejaan Jivraj, British Columbia Children's Hospital
- Investigators
- Kishore Mulpuri, MBBS, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784352
- Sponsor's protocol ID
- H18-03184
- Acronym
- VPRO
- Status last verified
- Feb 2020
- First submitted
- 13 Dec 2018
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03784352
- Acronym / sponsor ID
- VPRO / H18-03184
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- British Columbia Children's HospitalUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 21 Dec 2018 (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.
The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections.
Detailed description
Immediately following recruitment, demographic data and diseased related information (ie. location of cast/hardware, reason for cast/hardware placement and location and reason for botox injection) will be collected through self and/or guardian report. All data will be collected using REDCap (research electronic data capture). Using a parallel group design, patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure classifications (hardware or cast or staple or suture removal or cast application or botox injection) site of hardware or cast or staple or suture or botox injection), and reason for the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI) is completed by the patient to collect pre-procedural state anxiety measurements. Following this, patients in the control group will receive standard of care (SOC) which allows for the technician and/or accompanying guardian to try and distract and or console the patient as they normally would. The patients in the intervention group will receive SOC with Virtual Reality (VR) interaction a few minutes before, during and following the procedure (around 5-10minutes total). During the procedure the researcher will complete an observational survey (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure and their current pain levels post procedure while parent/guardians and cast technician will be asked to complete their respective satisfaction questionnaires. Following this, the child will be asked if they experienced any nausea at any point during the procedure, if they did, they will be asked to complete the BARF questionnaire to measure the amount of nausea experienced. Following completion of questionnaires, patients who were in the control group are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to incentivize recruitment for the study.
SOC will consist of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Experimental | Device: Virtual RealityThe intervention will consist of standard of care (SOC) in addition to the use of virtual reality. SOC consists of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) Patients assigned to the VR group will interact with VR through mobile-based VR googles. |
| No Virtual Reality (VR) | No intervention | –This arm will receive regular standard of care (SOC), the same that would be received if they were not enrolled in the study. SOC will include the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- child must be between the ages of 4 and 18 years
- the parent/guardians and child are both able to speak and read English or have a translator be present for them
Key exclusion criteria (3 listed)
- symptoms of respiratory or gastrointestinal infection
- visual, auditory, cognitive impairment or developmental delay
- history of seizures or epilepsy
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 |
|---|---|---|
| Virtual RealityA calming virtual reality game will be played | Device | Virtual Reality (VR) |
Primary outcome
Wong Baker Scale (WBS) for Procedural Pain
Time frame: Immediately post procedure
The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of "no pain" and "worst possible pain". There are six possible faces with "no pain" representing a score of 0 and "worst pain" representing a score of 10
Anxiety (state anxiety intraprocedure)
Time frame: Intraprocedure
Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include: Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.
5 secondary outcomes
Procedural Time
Time frame: Intraprocedure
Baxter Retching Faces (BARF) Scale for Nausea
Time frame: Immediately post procedure
State Anxiety Preprocedure
Time frame: Immediately pre-procedure
State Anxiety Postprocedure
Time frame: Immediately post procedure
Trait Anxiety
Time frame: Preprocedure while in the waiting area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- 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.
Kishore Mulpuri, MBBS principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Anxiety and Pain, run by British Columbia Children's Hospital at 1 site in Canada.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wong Baker Scale (WBS) for Procedural Pain (time frame: Immediately post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2020.