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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT04092803
Study groupRoleWhat they receive
GA for LPNo interventionPatients 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 LPExperimentalThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted17 Sep 2019
  2. Study start9 Sep 2019
  3. Primary completion16 Aug 2021
  4. Study completion30 Sep 2022

Resources

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)
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

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.

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Clinical Trial NCT04092803 | AzTrials