Clinical trial NCT04092803: Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
Official title: Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adults With Leukemia: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-17
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Pediatric and young adult patients 10-25 years of age
2. Lumbar puncture for chemotherapy per leukemia therapy
3. Cognitively appropriate
4. Assessed by child life specialist as appropriate to use VR
5. Previous LP with GA
6. Tested negative for COVID-19

Exclusion Criteria:

1. History of seizures
2. Active headache
3. Active nausea or vomiting
4. ASA (American Society of Anesthesiologists) greater than 4
5. Allergy to lidocaine, procaine, or propofol
6. Developmental delay
7. No previous LP with GA
8. Tested positive for COVID-19, or opted out of of COVID-19 testing

Primary outcomes:
measure: Success of completion of the LP with VR
timeFrame: 4 months
Secondary outcomes:
measure: Pain Visual Analogue Scale (Pain VAS)
timeFrame: 4 months
measure: Child Anxiety Meter-State (CAM-S)
timeFrame: 4 months
measure: Children's Fear Scale (CFS)
timeFrame: 4 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Physician
name: James Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References: