The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement

Fear Clinical Trial

Official title:

The Effects of Using an Interactive Game With Virtual Reality to Reduce the Pain and Fear for Children During an Intravenous Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558086
• Other study ID #: 108163-F
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: September 11, 2020

Study information

• Verified date: September 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children ages 6-12.

• Children who where 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

• Fear
• Pian

Intervention

Device:
• Virtual reality
To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.
• Photo book
To develop the intervention strategies of hospitalized school-age children with IV placement, using Photo book to further examine the effectiveness of reducing IV pain and fear.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei county

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 pin using the Wong-Baker Faces Pain Rating Scale (WBFPS). The scale contains six cartoon faces shwing 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.