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

Study Overview
=================
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.

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

Conditions
-----------------
Pian, Fear

Intervention / Treatment
-----------------
* Device: Virtual reality
* Device: Photo book


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduce pain and fear<br>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. | Device: Virtual reality<br>* 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.<br>|
| Experimental: control group<br>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. | Device: Photo book<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic play,virtual reality, intravenous placement, school-age, pain, fear