PainNCT04081935
Distraction Using VR for Children During IV in an Emergency Department
A study testing Virtual Reality in people with Pain and Fear, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- What is being tested?
- Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial
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.
- Being tested
- Virtual Reality
- Keywords
- school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.
| Study group | Role | What they receive |
|---|---|---|
| Reduce pain and fair | Experimental | 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. Receives: Device: Virtual Reality |
| Compared | No intervention | Normal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degrees of pain experienced by the children.
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 .
Measured: 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.
Measured: The posttests 8 min after the tourniquets were worn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Dec 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081935
- Sponsor's protocol ID
- 2017B002
- Status last verified
- Nov 2017
- First submitted
- 1 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.
PubMed 31715039
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04081935
- Acronym / sponsor ID
- 2017B002
- Keywords
- school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduce pain and fair | Experimental | Device: Virtual RealityTo 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. |
| Compared | No intervention | –Normal treatment |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Realityvirtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department. | Device | Reduce pain and fair |
Primary outcome
The degrees of pain experienced by the children.
Time frame: 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 .
The degrees of fear experienced by the children.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 31715039Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain and Fear, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degrees of pain experienced by the children. (time frame: The posttests 8 min after the tourniquets were worn.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.