Distraction Using VR for Children During IV in an Emergency Department

Not Applicable

Completed

• Conditions: Fear; Pain
• Interventions: Device: Virtual Reality

• Registration Number: NCT04081935
• Lead Sponsor: National Yang Ming Chiao Tung University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-12-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduce pain and fair	Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
The degrees of fear experienced by the children.	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.
The degrees of pain experienced by the children.	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 .

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei, Taiwan