Acute Lymphoblastic Leukemia, PediatricVIRALLNCT06722638
Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
A study testing Use of Virtual Reality Headset in people with Acute Lymphoblastic Leukemia, Pediatric, run by Children's National Research Institute at 1 site in United States.
Trial summary
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Use of Virtual Reality Headset
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)
- In maintenance phase of treatment
- Still have 2 maintenance cycles planned
- Aged 7 and over
- Patient able to speak English
- Caregiver able to complete consent and study questionnaires in English or Spanish
Who cannot join
- Relapsed or refractory disease
- Previously required ultrasound guided LP procedure
- Already does LPs without anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.
Read the detailed description
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will be long-term survivors. To help prevent disease recurrence in the central nervous system, patients receive intrathecal chemotherapy, delivered via lumbar puncture, at least 20 times over the course of treatment. Although critical for cure, this component of treatment is a risk factor for neurocognitive impairments that can subsequently affect the daily living skills and academic achievement of survivors. It is now understood that the general anesthesia used to manage pain and anxiety during lumbar punctures also contributes to impairments in neurocognitive functioning. Recent studies have demonstrated that the use of general anesthesia can be decreased by using local anesthesia and offering oral or IV anxiolytic medications. The investigators propose that adding virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), to local anesthesia and the option for anxiolytics will be superior to using those medications alone. The investigators' aim in this study is to demonstrate the feasibility of using VR, in conjunction with local anesthesia and oral/IV anti-anxiety medications, in participants 7 years of age and older with ALL in the maintenance phase of treatment. The multi-disciplinary investigator team, which includes experts in pediatric oncology, survivorship, patient reported outcomes, VR technology and VR content, is uniquely suited to successfully develop, implement, and evaluate this strategy. The investigators' long-term objective is to create a scalable and sustainable alternative to general anesthesia that will adequately manage pain and anxiety without compromising neurocognitive function. By systematically working towards this long-term objective, the investigators seek to help survivors of childhood cancer lead happy, normal lives, free from acquired neurocognitive impairment.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Use of Virtual Reality Headset
- Keywords
- Virtual Reality, Lumbar Puncture
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Virtual Reality HeadsetOther
Virtual Reality Headsets will be used to augment pain and anxiety management during therapeutic LPs in children with acute lymphoblastic leukemia
| Study group | Role | What they receive |
|---|---|---|
| VR Arm | Experimental | Pain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered. Receives: Other: Use of Virtual Reality Headset |
| GA Arm | No intervention | Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome: Feasibility
Number of participants able to receive intrathecal chemotherapy while using Virtual Reality to augment local anesthesia and the option of an anxiolytic for management of pain and anxiety during the lumbar puncture procedure.
Measured: At time of Procedure
Secondary outcomes (1)
Secondary Outcome: Acceptability
Number of participants who, having successfully received intrathecal chemotherapy using Virtual Reality with local anesthesia and the option of an anxiolytic, choose to undergo the next procedrue under the same circumstances.
Measured: 1-3 months after first Lumbar Puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Responsible party
- Principal investigator, Jennifer Levine, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722638
- Sponsor's protocol ID
- STUDY00000820
- Acronym
- VIRALL
- Status last verified
- Dec 2024
- First submitted
- 2 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will be able to request access.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06722638
- Acronym / sponsor ID
- VIRALL / STUDY00000820
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- Virtual Reality, Lumbar Puncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.
Detailed description
Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will be long-term survivors. To help prevent disease recurrence in the central nervous system, patients receive intrathecal chemotherapy, delivered via lumbar puncture, at least 20 times over the course of treatment. Although critical for cure, this component of treatment is a risk factor for neurocognitive impairments that can subsequently affect the daily living skills and academic achievement of survivors. It is now understood that the general anesthesia used to manage pain and anxiety during lumbar punctures also contributes to impairments in neurocognitive functioning. Recent studies have demonstrated that the use of general anesthesia can be decreased by using local anesthesia and offering oral or IV anxiolytic medications. The investigators propose that adding virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), to local anesthesia and the option for anxiolytics will be superior to using those medications alone. The investigators' aim in this study is to demonstrate the feasibility of using VR, in conjunction with local anesthesia and oral/IV anti-anxiety medications, in participants 7 years of age and older with ALL in the maintenance phase of treatment. The multi-disciplinary investigator team, which includes experts in pediatric oncology, survivorship, patient reported outcomes, VR technology and VR content, is uniquely suited to successfully develop, implement, and evaluate this strategy. The investigators' long-term objective is to create a scalable and sustainable alternative to general anesthesia that will adequately manage pain and anxiety without compromising neurocognitive function. By systematically working towards this long-term objective, the investigators seek to help survivors of childhood cancer lead happy, normal lives, free from acquired neurocognitive impairment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Arm | Experimental | Other: Use of Virtual Reality HeadsetPain and anxiety management in this arm will include: topical numbing cream 30 minutes prior to the scheduled procedure, option for a 0.05mg/kg (max 2 mg) oral/IV dose of lorazepam. VR headsets will be donned. After sterile cleaning of the lumbar spine area, lidocaine will be injected between L3-4 or L4-5 for local anesthetic. A 22-gauge needle of appropriate length (1.5, 2.5, 3.5 inch) will be used to access the intrathecal space. Cerebral spinal fluid will be collected for evaluation (standard procedure) and IT chemotherapy will be administered. |
| GA Arm | No intervention | –Pain and anxiety in this arm will be managed with general anesthesia, usually propofol, which is the current standard of care at Children's National Hospital. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)
- In maintenance phase of treatment
- Still have 2 maintenance cycles planned
- Aged 7 and over
- Patient able to speak English
Key exclusion criteria (3 listed)
- Relapsed or refractory disease
- Previously required ultrasound guided LP procedure
- Already does LPs without anesthesia
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 |
|---|---|---|
| Use of Virtual Reality HeadsetVirtual Reality Headsets will be used to augment pain and anxiety management during therapeutic LPs in children with acute lymphoblastic leukemia | Other | VR Arm |
Primary outcome
Primary Outcome: Feasibility
Time frame: At time of Procedure
Number of participants able to receive intrathecal chemotherapy while using Virtual Reality to augment local anesthesia and the option of an anxiolytic for management of pain and anxiety during the lumbar puncture procedure.
1 secondary outcome
Secondary Outcome: Acceptability
Time frame: 1-3 months after first Lumbar Puncture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes. Researchers will be able to request access.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Virtual Reality Headset in people with Acute Lymphoblastic Leukemia, Pediatric, run by Children's National Research Institute 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 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: looking for participants now, as of the sponsor's last update on 9 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Levine, MD (202-476-2140, jlevine@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: Feasibility (time frame: At time of Procedure). 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 9 Dec 2024.