Distraction Using VR for Children During IV in an Emergency Department

Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial

Exploring the use of virtual reality as a distracting intervention strategy for school-age children to receive intravenous placement in emergency department, and further understand the effectiveness of reducing pain and fear during the invasive procedure.

Study Overview

• Status: Completed
• Conditions: Pain; Fear
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang-Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children ages 7-12
• Children who were clearly conscious
• Children who agreed and were required to receive intravenous injections after physicians' diagnoses
• Children and their primary caregivers who could communicate in Mandarin or Taiwanese
• Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion Criteria:

• Children with developmental delay, epilepsy, or heart diseases
• Children undergoing chemotherapy; children who were visually or hearing impaired
• Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters
• Children who had sustained head trauma in the past month
• Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
• Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
• Children who received two or more intravenous injections and had their blood drawn only one time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduce pain and fair; To determine whether the virtual reality as a distracting intervention could reduce pain and fear in school-age children receiving intravenous injections at an emergency department.	Device: Virtual Reality; virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.
No Intervention: Compared; Normal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degrees of pain experienced by the children.	Measurement of pain using the Wong-Baker FACES Pain Rating Scale(WBFPS). The scale contains six cartoon faces showing pain ratings of 0-10, which are, from left to right, no pain (0), a little pain (2), mild pain (4), average pain (6), severe pain (8), and excruciating pain (10).The children, primary caregivers, and nurses were asked to select the faces that best described the pain levels experienced by the children receiving intravenous injections; the pain levels were subsequently converted into numerical values .	The posttests 8 min after the tourniquets were worn.
The degrees of fear experienced by the children.	Measurement of fear using the Choldren Fear Scale(CFS).The scale consists of five cartoon faces showing fear ratings of 0-4, which were no fear (0), a little fear (1), some fear (2), very fear(3) and extreme fear (4). The children, primary caregivers, and nurses were asked to select the faces that best described the fear levels of the children receiving intravenous injections. The pain levels were subsequently converted into numerical values.	The posttests 8 min after the tourniquets were worn.

Collaborators and Investigators

• Sponsor: National Yang Ming University

Publications and helpful links

General Publications

• Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2017B002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No