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Completed

NCT Number: NCT04081935

Distraction Using VR for Children During IV in an Emergency Department

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang-Ming University

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The degrees of pain experienced by the children.

    Time frame: The posttests 8 min after the tourniquets were worn.

    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 .

  2. The degrees of fear experienced by the children.

    Time frame: The posttests 8 min after the tourniquets were worn.

    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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2019
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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