Distraction Using VR for Children During IV in an Emergency Department

NCT04081935 | Completed DMC

• 1 other identifier: 2017B002
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Fear

Keywords

school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Reduce pain and fair

EXPERIMENTAL

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

Compared

NO INTERVENTION

Normal treatment

Interventions

Virtual Reality DEVICE

virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.

Reduce pain and fair

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31715039 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 9, 2019
• Study Start: December 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: September 9, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)