LeukemiaNCT04092803
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
A study testing Virtual Reality in people with Leukemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this feasibility study is to determine if Virtual Reality (VR) can be adequately used as an alternative to General Anesthesia (GA) for Lumbar Punctures (LP). Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 30 Sep 2022
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric and young adult patients 10-25 years of age
- Lumbar puncture for chemotherapy per leukemia therapy
- Cognitively appropriate
- Assessed by child life specialist as appropriate to use VR
- Previous LP with GA
- Tested negative for COVID-19
Who cannot join
- History of seizures
- Active headache
- Active nausea or vomiting
- ASA (American Society of Anesthesiologists) greater than 4
- Allergy to lidocaine, procaine, or propofol
- Developmental delay
- No previous LP with GA
- Tested positive for COVID-19, or opted out of of COVID-19 testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adults With Leukemia: a Feasibility Study
The goal of this feasibility study is to determine if Virtual Reality (VR) can be adequately used as an alternative to General Anesthesia (GA) for Lumbar Punctures (LP).
Read the detailed description
The primary purpose of this study is to determine the feasibility of implementing VR as an alternative to general anesthesia in adolescents and young adults with leukemia who undergo LPs for maintenance of chemotherapy. The patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Success will be defined as successful performance of the procedure with VR instead of GA.
Additionally, we plan to administer questionnaires to all patients approached for the trial if they are willing, even if they decide not to use VR for their LP. These questionnaires are listed below.
Studies have linked the use of technology with decreased distress, increased cooperation, and improved pain management. For example, pediatric patients who had access to a video game to engage for distraction during anesthesia induction for surgery were less distressed and more cooperative during mask induction. In children and adolescents requiring port access VR distraction was significantly better than standard of care in terms of reducing physiological arousal (i.e., pulse rate) and pain ratings. VR has been utilized effectively in the management of pediatric and adult wound care, burn care, and dressing changes. Patients who had dressing changes while immersed in VR used less pain medication, had lower pain scores and often requested to use VR for future dressing changes all while having their procedures take less time. Simple distraction techniques might not be enough. One study evaluated the effectiveness of using augmented reality with children undergoing burn dressing changes. They compared augmented reality to standard distraction with an age appropriate video game. The study found augmented reality reduced pain scores significantly better than video game distraction.
When not accompanied by appropriate pain control, stressful and invasive medical procedures can lead to posttraumatic stress symptoms and negative reactions or noncompliance to subsequent medical experiences. Specifically, adults who experienced more medical fear and pain as children were more likely to rate their adult medical fear and pain higher and avoid medical care. Pharmacological strategies alone are often not enough to effectively manage a child's pain. Non-pharmacological pain management uses alternative strategies, such as distraction, to replace or augment medication to help reduce a child's pain. VR systems have been successfully trialed in a small number of patients, mostly adolescents and adults. VR has reliably demonstrated decreased pain, anxiety, suffering, time spent thinking about pain and perceived time spent in a medical procedure.
Typically, VR has to be experienced seated upright or standing with few exceptions because of the design of the software. Patients underoing LP are often required to lay laterally, as is the case with this study. Therefore, we will be using VR software (Pebbles the Penguin and SpacePups, Weightless Studios) that is age appropriate for the study population, engaging enough for young adults, and designed to be reoriented to the patient's position.
The goal of this feasibility study is to determine if VR can be adequately used as an alternative to GA for LP. Utilizing distraction will eliminate the risk associated with general anesthesia, and the accompanying inconvenience of general anesthetic exposure on these patients perioperatively, as well as long term. Additionally, we wish to decrease the burden of cost for these procedures as currently practiced. LPs performed under GA require the presence of an anesthesiologist, medications, and recovery staff, all of which add increased cost to the procedure. With this VR system, there is a one time cost associated with the purchase of the system (in our case, the VR system was donated to our hospital by a non-profit called The Starlight Foundation), and the system can be used multiple times on multiple patients.
- Conditions
- Leukemia
- Being tested
- Virtual Reality
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
The system includes a VR headset with VR software already loaded in to it.
| Study group | Role | What they receive |
|---|---|---|
| GA for LP | No intervention | Patients who decline to undergo an LP with VR will be asked if they would be willing to participate by answering questionnaires specific to their pre procedure anxiety. This will include questionnaires 2 and 3 from above. The investigators will also plan to collect vital sign data if they agree to participate in that capacity. |
| VR for LP | Experimental | The patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Patients who agree to undergo an LP with VR will be assessed by a certified child life specialist (CCLS) to determine whether the patient is an appropriate candidate for using VR.The system includes a VR headset with VR software already loaded in to it. The VR software to be used is either a game called "Pebbles the Penguin" or "SpacePups" (Weightless Studios). Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of completion of the LP with VR
This is a feasibility study with the primary outcome defined as success of completion of the Lumbar Puncture with Virtual Reality.
Measured: 4 months
Secondary outcomes (3)
Pain Visual Analogue Scale (Pain VAS)
This is a numerical scale from 0 to 10, 0 being no pain, 10 being the worst possible pain.
Measured: 4 months
Child Anxiety Meter-State (CAM-S)
The CAM-S is a vertical analog scale for child self-report of state anxiety. Children are asked to rate how nervous or worried they feel "right now" by marking a line on a visual depiction of a thermometer. Lines closet to the bottom of the thermometer indicate less worry, while lines towards the top of the thermometer indicate more worry. The scale ranges from Calm (score of 0) to very very nervous (score of 100)
Measured: 4 months
Children's Fear Scale (CFS)
The Children's fear Scale is a one-item scale that consists of a row of faces with expressions ranging from no fear (score of 0) to extreme fear (score of 4). Children are asked to choose the face that most closely reflects how anxious or fearful they are feeling.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start9 Sep 2019
- Primary completion16 Aug 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Thomas, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092803
- Sponsor's protocol ID
- 19-0994.cc
- Other IDs
- P30CA046934
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2019
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adults With Leukemia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04092803
- Acronym / sponsor ID
- 19-0994.cc
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 17 Sep 2019 (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 goal of this feasibility study is to determine if Virtual Reality (VR) can be adequately used as an alternative to General Anesthesia (GA) for Lumbar Punctures (LP).
Detailed description
The primary purpose of this study is to determine the feasibility of implementing VR as an alternative to general anesthesia in adolescents and young adults with leukemia who undergo LPs for maintenance of chemotherapy. The patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Success will be defined as successful performance of the procedure with VR instead of GA.
Additionally, we plan to administer questionnaires to all patients approached for the trial if they are willing, even if they decide not to use VR for their LP. These questionnaires are listed below.
Studies have linked the use of technology with decreased distress, increased cooperation, and improved pain management. For example, pediatric patients who had access to a video game to engage for distraction during anesthesia induction for surgery were less distressed and more cooperative during mask induction. In children and adolescents requiring port access VR distraction was significantly better than standard of care in terms of reducing physiological arousal (i.e., pulse rate) and pain ratings. VR has been utilized effectively in the management of pediatric and adult wound care, burn care, and dressing changes. Patients who had dressing changes while immersed in VR used less pain medication, had lower pain scores and often requested to use VR for future dressing changes all while having their procedures take less time. Simple distraction techniques might not be enough. One study evaluated the effectiveness of using augmented reality with children undergoing burn dressing changes. They compared augmented reality to standard distraction with an age appropriate video game. The study found augmented reality reduced pain scores significantly better than video game distraction.
When not accompanied by appropriate pain control, stressful and invasive medical procedures can lead to posttraumatic stress symptoms and negative reactions or noncompliance to subsequent medical experiences. Specifically, adults who experienced more medical fear and pain as children were more likely to rate their adult medical fear and pain higher and avoid medical care. Pharmacological strategies alone are often not enough to effectively manage a child's pain. Non-pharmacological pain management uses alternative strategies, such as distraction, to replace or augment medication to help reduce a child's pain. VR systems have been successfully trialed in a small number of patients, mostly adolescents and adults. VR has reliably demonstrated decreased pain, anxiety, suffering, time spent thinking about pain and perceived time spent in a medical procedure.
Typically, VR has to be experienced seated upright or standing with few exceptions because of the design of the software. Patients underoing LP are often required to lay laterally, as is the case with this study. Therefore, we will be using VR software (Pebbles the Penguin and SpacePups, Weightless Studios) that is age appropriate for the study population, engaging enough for young adults, and designed to be reoriented to the patient's position.
The goal of this feasibility study is to determine if VR can be adequately used as an alternative to GA for LP. Utilizing distraction will eliminate the risk associated with general anesthesia, and the accompanying inconvenience of general anesthetic exposure on these patients perioperatively, as well as long term. Additionally, we wish to decrease the burden of cost for these procedures as currently practiced. LPs performed under GA require the presence of an anesthesiologist, medications, and recovery staff, all of which add increased cost to the procedure. With this VR system, there is a one time cost associated with the purchase of the system (in our case, the VR system was donated to our hospital by a non-profit called The Starlight Foundation), and the system can be used multiple times on multiple patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA for LP | No intervention | –Patients who decline to undergo an LP with VR will be asked if they would be willing to participate by answering questionnaires specific to their pre procedure anxiety. This will include questionnaires 2 and 3 from above. The investigators will also plan to collect vital sign data if they agree to participate in that capacity. |
| VR for LP | Experimental | Other: Virtual RealityThe patients in this study will be presented the opportunity to use VR instead of undergo GA for a LP. Patients who agree to undergo an LP with VR will be assessed by a certified child life specialist (CCLS) to determine whether the patient is an appropriate candidate for using VR.The system includes a VR headset with VR software already loaded in to it. The VR software to be used is either a game called "Pebbles the Penguin" or "SpacePups" (Weightless Studios). |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pediatric and young adult patients 10-25 years of age
- Lumbar puncture for chemotherapy per leukemia therapy
- Cognitively appropriate
- Assessed by child life specialist as appropriate to use VR
- Previous LP with GA
Key exclusion criteria (8 listed)
- History of seizures
- Active headache
- Active nausea or vomiting
- ASA (American Society of Anesthesiologists) greater than 4
- Allergy to lidocaine, procaine, or propofol
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 RealityThe system includes a VR headset with VR software already loaded in to it. | Other | VR for LP |
Primary outcome
Success of completion of the LP with VR
Time frame: 4 months
This is a feasibility study with the primary outcome defined as success of completion of the Lumbar Puncture with Virtual Reality.
3 secondary outcomes
Pain Visual Analogue Scale (Pain VAS)
Time frame: 4 months
Child Anxiety Meter-State (CAM-S)
Time frame: 4 months
Children's Fear Scale (CFS)
Time frame: 4 months
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 26 Jul 2024.
- 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.
James Thomas, MD principal investigator
Physician
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 Leukemia, run by University of Colorado, Denver 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 6 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: finished, as of the sponsor's last update on 26 Jul 2024. 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?
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?
Success of completion of the LP with VR (time frame: 4 months). 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 26 Jul 2024.