Pain, Acuteven-VRNCT06243419
Veın Imagıng Devıce And Vırtual Realıty
A study testing vein viewer, virtual reality and vein viewer and virtual reality in people with Pain, Acute and Emotional Distress, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pain, Acute, Emotional Distress, Fear
- What is being tested?
- vein viewer, virtual reality and vein viewer and virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 22 Dec 2022
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent from the child and parent
Who cannot join
- Need for urgent resuscitation
- Having a fever (>37.5C) and severe dehydration
- The fact that the patient had taken analgesics before the PIC intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Vein Imaging Device And Virtual Reality On Catheter Intervention Success, Procedure Related Outcomes During Peripheral Intravenous Catheterization in Children
The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.
Read the detailed description
The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.
- Conditions
- Pain, Acute, Emotional Distress, Fear, Anxiety State
- Being tested
- vein viewer, virtual reality, vein viewer and virtual reality
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vein viewerDevice
The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.
virtual realityDevice
The child watched the application by wearing virtual glasses during the PIC insertion
vein viewer and virtual realityDevice
The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.
The child watched the application by wearing virtual glasses during the PIC insertion
| Study group | Role | What they receive |
|---|---|---|
| vein viewer | Experimental | The vein imaging device was used before the vascular access attempt Receives: Device: vein viewer |
| virtual reality | Experimental | wearing virtual reality glasses Receives: Device: virtual reality |
| vein viewer and virtual reality | Experimental | The vein imaging device was used before the vascular access attempt and wearing virtual reality glasses Receives: Device: vein viewer and virtual reality |
| Control group | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assesed by Wong-Baker FACES
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.
Measured: immediately after the vascular access (on average 2-3 minutes later)
Anxiety assesed by Children Anxiety Meter-State
The Children's Anxiety Meter. The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). higher scores mean a worse outcome.
Measured: immediately after the vascular access (on average 2-3 minutes later)
Fear assesed by Child Fear Scale
The Child Fear Scale. This one-item scale measures procedure-related fear in children, consisting of five sex-neutral faces ranging from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no-fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome.
Measured: immediately after the vascular access (on average 2-3 minutes later)
the success of peripheral intravenous catheter (PIC) placement
first IV attempt
Measured: at PIC insertion
Emotional Appearance by Emotional Appearance Scale for Children
This scale allows direct behavioral observation, and consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represent the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. A higher scale score indicates the appearance of more negative emotional behaviors.
Measured: before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 May 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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 Pain, AcuteStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, Assoc. Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243419
- Sponsor's protocol ID
- ven-VR
- Acronym
- ven-VR
- Status last verified
- Feb 2024
- First submitted
- 24 May 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Can M, Ozalp Gerceker G. The effect of the Veinlite PEDI2 and passive virtual reality distraction on peripheral catheter insertion-related emotional behavior, pain, fear, and anxiety of children: A randomized controlled trial. J Pediatr Nurs. 2024 Sep-Oct;78:e227-e235. doi: 10.1016/j.pedn.2024.07.010. Epub 2024 Jul 26.
PubMed 39060169
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Vein Imaging Device And Virtual Reality On Catheter Intervention Success, Procedure Related Outcomes During Peripheral Intravenous Catheterization in Children
- ClinicalTrials.gov ID
- NCT06243419
- Acronym / sponsor ID
- ven-VR / ven-VR
- Conditions
- Pain, Acute, Emotional Distress, Fear, Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 6 Feb 2024 (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.
The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.
Detailed description
The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vein viewer | Experimental | Device: vein viewerThe vein imaging device was used before the vascular access attempt |
| virtual reality | Experimental | Device: virtual realitywearing virtual reality glasses |
| vein viewer and virtual reality | Experimental | Device: vein viewer and virtual realityThe vein imaging device was used before the vascular access attempt and wearing virtual reality glasses |
| Control group | No intervention | –standard care |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent from the child and parent
Key exclusion criteria (3 listed)
- Need for urgent resuscitation
- Having a fever (>37.5C) and severe dehydration
- The fact that the patient had taken analgesics before the PIC intervention.
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 |
|---|---|---|
| vein viewerThe PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined. | Device | vein viewer |
| virtual realityThe child watched the application by wearing virtual glasses during the PIC insertion | Device | virtual reality |
| vein viewer and virtual realityThe PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined. The child watched the application by wearing virtual glasses during the PIC insertion | Device | vein viewer and virtual reality |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: immediately after the vascular access (on average 2-3 minutes later)
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.
Anxiety assesed by Children Anxiety Meter-State
Time frame: immediately after the vascular access (on average 2-3 minutes later)
The Children's Anxiety Meter. The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). higher scores mean a worse outcome.
Fear assesed by Child Fear Scale
Time frame: immediately after the vascular access (on average 2-3 minutes later)
The Child Fear Scale. This one-item scale measures procedure-related fear in children, consisting of five sex-neutral faces ranging from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no-fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome.
the success of peripheral intravenous catheter (PIC) placement
Time frame: at PIC insertion
first IV attempt
Emotional Appearance by Emotional Appearance Scale for Children
Time frame: before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]
This scale allows direct behavioral observation, and consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represent the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. A higher scale score indicates the appearance of more negative emotional behaviors.
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 6 Feb 2024.
- Derived from this study: PubMed 39060169Can M, Ozalp Gerceker G. The effect of the Veinlite PEDI2 and passive virtual reality distraction on peripheral catheter insertion-related emotional behavior, pain, fear, and anxiety of children: A randomized controlled trial. J Pediatr Nurs. 2024 Sep-Oct;78:e227-e235. doi: 10.1016/j.pedn.2024.07.010. Epub 2024 Jul 26.
- 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.
Gülçin Özalp Gerçeker, Assoc. Prof. principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vein viewer, virtual reality and vein viewer and virtual reality in people with Pain, Acute and Emotional Distress, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 6 Feb 2024. 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 Turkey (Türkiye). 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?
Pain assesed by Wong-Baker FACES (time frame: immediately after the vascular access (on average 2-3 minutes later)). The study lists 5 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 NCT06243419, 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 6 Feb 2024.