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

Not Applicable

Completed

• Conditions: Pian; Fear
• Interventions: Device: Photo book; Device: Virtual reality

• Registration Number: NCT04558086
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-05
• Status Verified: 2020-09
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	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.
Reduce pain and fear	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.

Primary Outcome Measures

Name	Time	Method
The degrees of pain experienced by the children.	The posttests 8 min after the tourniquets were worn.	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 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.

Trial Locations

Locations (1)

National Yang-Ming University; 🇨🇳 Taipei county, Taiwan