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

NCT04092803 | Completed DMC

• 2 other identifiers: 19-0994.ccP30CA046934
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Leukemia

Outcome Measures

Primary Outcomes (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.

  4 months

Secondary Outcomes (3)

• Pain Visual Analogue Scale (Pain VAS)

  4 months

• Child Anxiety Meter-State (CAM-S)

  4 months

• Children's Fear Scale (CFS)

  4 months

Study Arms (2)

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).

Other: Virtual Reality

Interventions

Virtual Reality OTHER

The system includes a VR headset with VR software already loaded in to it.

VR for LP

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• James Thomas, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: September 17, 2019
• Study Start: September 9, 2019
• Primary Completion: August 16, 2021
• Study Completion: September 30, 2022
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)