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Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu

Primary Purpose

Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

GA for LP

VR for LP

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.

Full Information

First Posted
June 11, 2019
Last Updated
July 24, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04092803
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GA for LP
Arm Type
No Intervention
Arm Description
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.
Arm Title
VR for LP
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
The system includes a VR headset with VR software already loaded in to it.
Primary Outcome Measure Information:
Title
Success of completion of the LP with VR
Description
This is a feasibility study with the primary outcome defined as success of completion of the Lumbar Puncture with Virtual Reality.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Pain Visual Analogue Scale (Pain VAS)
Description
This is a numerical scale from 0 to 10, 0 being no pain, 10 being the worst possible pain.
Time Frame
4 months
Title
Child Anxiety Meter-State (CAM-S)
Description
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)
Time Frame
4 months
Title
Children's Fear Scale (CFS)
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Gerson
Phone
720-777-9843
Email
jennifer.gerson@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Thomas, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Gerson
Phone
720-777-9843
Email
jennifer.gerson@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
James Thomas

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu

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