Distraction Using VR for Children During IV in an Emergency Department

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081935
• Other study ID #: 2017B002
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: November 2017
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Fear
• Pain

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.