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Distraction Using VR for Children During IV in an Emergency Department

Primary Purpose

Pain, Fear

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reduce pain and fair

Compared

Arm Description

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.

Normal treatment

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2019
Last Updated
September 6, 2019
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04081935
Brief Title
Distraction Using VR for Children During IV in an Emergency Department
Official Title
Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear
Keywords
school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduce pain and fair
Arm Type
Experimental
Arm Description
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.
Arm Title
Compared
Arm Type
No Intervention
Arm Description
Normal treatment
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.
Primary Outcome Measure Information:
Title
The degrees of pain experienced by the children.
Description
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 .
Time Frame
The posttests 8 min after the tourniquets were worn.
Title
The degrees of fear experienced by the children.
Description
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.
Time Frame
The posttests 8 min after the tourniquets were worn.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31715039
Citation
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.
Results Reference
derived

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Distraction Using VR for Children During IV in an Emergency Department

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