Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization

NCT03681730 | Unknown

• 1 other identifier: H18-00771
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used. Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.

Conditions

Intravenous Catheterization

Keywords

Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain using the Faces Pain Scale - Revised.

  Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.

  Pain is reported by children immediately following completion of the IV start

Secondary Outcomes (7)

• Anxiety using the Venham Situational Anxiety Score

  Anxiety is reported by children immediately following completion of the IV start

• Patient Satisfaction determined by Global Rating Scale

  Satisfaction questions are reported by children immediately following completion of the IV start

• Patient Satisfaction determined qualitatively by an open ended question

  Satisfaction questions are reported by children immediately following completion of the IV start

• Parent Satisfaction determined qualitatively by an open ended question

  Satisfaction question is reported by parents immediately following completion of the IV start

• Medication Dose

  These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.

Device: Virtual Reality

Control (Standard-of-Care)

NO INTERVENTION

Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.

Interventions

Virtual Reality DEVICE

Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.

Virtual Reality

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 6 - \<17
• The managing physician determines a need for an intravenous catheterization (IV) procedure
• Parents will sign a consent form and children will sign an assent form

You may not qualify if:

• Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)
• Triage Category 1 (resuscitation)
• Facial features or injury prohibiting wearing the VR goggles

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Related Publications (1)

• Goldman RD, Behboudi A. Virtual reality for intravenous placement in the emergency department-a randomized controlled trial. Eur J Pediatr. 2021 Mar;180(3):725-731. doi: 10.1007/s00431-020-03771-9. Epub 2020 Aug 10.

  PMID: 32779029 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ran D Goldman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran D Goldman, MD

CONTACT

604-875-2345; rgoldman@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: September 24, 2018
• Study Start: May 2, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)