- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558086
The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement
September 16, 2020 updated by: National Yang Ming University
The Effects of Using an Interactive Game With Virtual Reality to Reduce the Pain and Fear for Children During an Intravenous Placement
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taipei county, Taiwan, 112
- National Yang-Ming University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reduce pain and fear
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.
|
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.
|
Experimental: control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degrees of fear experienced by the children.
Time Frame: The posttests 8 min after the tourniquets were worn.
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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.
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The posttests 8 min after the tourniquets were worn.
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The degrees of pain experienced by the children.
Time Frame: 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 .
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The posttests 8 min after the tourniquets were worn.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2020
Primary Completion (Actual)
September 11, 2020
Study Completion (Actual)
September 11, 2020
Study Registration Dates
First Submitted
September 16, 2020
First Submitted That Met QC Criteria
September 16, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 108163-F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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