Virtual RealityR3VPNCT05066061
Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP)
A study testing anxiolytic and analgesic gas and Virtual reality mask in people with Virtual Reality and Catheterization, Peripheral Venous, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Main objective : Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Virtual Reality, Catheterization, Peripheral Venous, Children, Only
- What is being tested?
- anxiolytic and analgesic gas and Virtual reality mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2021to 3 Nov 2025
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 6 to 11 years old requiring an intravenous catheter insertion in a pediatric day hospital at the Clermont Ferrand University Hospital.
- Subjects and their parents who were informed about the study and gave informed consent
- Subjects who have had local anesthetic cream for 1-5 hours at the puncture site
- On the first attempt to apply intravenous catheter on the day of inclusion
- Subjects and their parents able to use the self-report scales proposed in the study.
Who cannot join
- Children from 6 to 11 :
- Having a modification of pain's integration (spina bifida for example)
- Having received an analgesic before the care
- Requiring contact isolation
- With a history of seizures or motion sickness
- Born very prematurely (< 28 SA)
Show all 9Show fewer
- Presenting a contraindication to the use of the local anesthetic cream
- Presenting a contraindication to the use of the anesthetic and anxiolytic gas.
- Presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post traumatic stress syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Contribution of Virtual Reality Distraction in Peripheral Intravenous Catheter Insertion to Children From 6 to 11 Years in a Pediatric Day Hospital
Main objective :
Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.
Hypothesis :
Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.
Read the detailed description
Peripheral intravenous catheter insertion is a difficult, painful and anxiety-provoking procedure for hospitalized children, with the possible memorization of pain being even more present for children with chronic pathologies.
Memorization of painful events plays an essential role in anticipating the next experience and can lead to long-term consequences. The child, whose cognitive faculties are gradually developing and whose emotions are very invasive, is particularly concerned by this repercussion.
Different techniques can be used to prevent pain during care (apart from "human" techniques such as comfort, distraction by voice, information on gesture... which are part of good practice).
The national drug safety agency recommends the use of the local anesthetic cream and/or an equimolar mixture of oxygen and nitrous oxide causing surface anesthesia and relaxation and amnesia of the gesture.
Immersion in virtual reality allows to saturate the child's sensorially (3D vision, hearing and kinesthetic proprioception) thus reducing nociceptive perceptions and anxiety. His attention is focused by the virtual animation proposed during this experience. There are many devices (glasses, masks...) as well as various programs more or less specific to care situations, some of them allow to interact with games.
There is no randomized study comparing the efficacy on pain, satisfaction and anxiety of peripheral intravenous catheter insertion with the three possible analgesia techniques: local anesthetic cream / local anesthetic cream and anesthetic and anxiolytic gas / local anesthetic cream and virtual reality mask, nor on the medico-economic impact respecting standard 6 on homogeneous pediatric age groups in clinical trials.
This is a randomized, open-label, three-armed, parallel, single-center therapeutic trial comparing an analgesic strategy using two authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for intravenous catheter insertion in children aged 6 to 11 years old hospitalized in the day hospital of Clermont Ferrand University Hospital.
The control arm is the local anesthetic cream arm, the experimental arms are the local anesthetic cream + anesthetic and anxiolytic gas arm on the one hand and the local anesthetic cream + virtual reality mask type Oculus quest® with interactive program on the other hand.
After informing and obtaining the consent of the child and his parents, will be measured the pain/anxiety/salivary cortisol/heart rate of the child; anxiety of the parents. The nurse evaluates the venous capital of the child then times the time of care and collects (among other things) the number of operators required. Immediately after the treatment, and then 15 to 30 minutes after the insertion will be measured the pain/anxiety/heart rate of the child; anxiety of the parents. The salivary cortisol at 20 minutes after catheter insertion will reflect the stress felt by the child during the procedure. Finally, the satisfaction of the child, parents, nurses will be collected 30 minutes after the care.
After statistical analysis of these three arms, it will be possible to determine the value of the anesthetic and anxiolytic gas and the virtual reality mask to reduce the child's pain and anxiety during the intravenous catheter insertion.
- Being tested
- control arm, anxiolytic and analgesic gas, Virtual reality mask
- Keywords
- virtual reality mask, children from 6 to 11, peripheral intravenous catheter insertion, pediatric's day hospital
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control armOther
usual process
anxiolytic and analgesic gasOther
add relaxing gas
Virtual reality maskDevice
use Virtual reality mask Oculus Quest with age-appropriate software
| Study group | Role | What they receive |
|---|---|---|
| standard | Active comparator | Only use local anesthetic cream Receives: Other: control arm |
| anxiolytic gas | Experimental | Use local anesthetic cream and anesthetic and anxiolytic gas Receives: Other: anxiolytic and analgesic gas |
| virtual reality | Experimental | Use local anesthetic cream and virtual reality mask Receives: Device: Virtual reality mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline child's pain at 30 minutes after the care
self-evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10 represents the worst pain we can feel
Measured: - Before the care - Immediately after the care - 15 to 30 minutes after the care
Secondary outcomes (5)
change from baseline child's anxiety at 30 minutes after the care
self-evaluation of children's anxiety with numerical scale from 1 to 10 (10= worst score)
Measured: -before the care -immediately after the care -15 to 30 minutes after the care
change from baseline heart rate at 30 minutes after the care
- Measure of heart rate (number of heartbeats in one minute)
Measured: -before the care -immediately after the care -15 to 30 minutes after the care
change from baseline salivary cortisol at 30 minutes after the care
- salivary cortisol : results in µg/l
Measured: -before the care -15 to 30 minutes after the care
change from baseline parents' anxiety at 30 minutes after the care
self-evaluation of parents' anxiety with scale number from 0 to 10 (10= worst score)
Measured: -before the care - immediately after the care - 15 to 30 minutes after the care
evaluation of the care with satisfaction questionnaire
satisfaction of the care for children, parents and nurses with satisfaction questionnaire for children : a score from 1 to 3 (3= best score, very satisfied) for parents and nurses : a score from 1 to 5 (5= best score, very satisfied)
Measured: 30 minutes after the care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start6 Dec 2021
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Why it stopped: recruiting difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, open-label, three-arm parallel, single-center therapeutic trial.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMMANUELLE LABRAISE, NURSE, Principal investigator, ClermontFerrandUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066061
- Sponsor's protocol ID
- AOI 2020 SAVEL
- Other IDs
- 2020-A03229-30
- Acronym
- R3VP
- Status last verified
- Nov 2025
- First submitted
- 6 Sep 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Contribution of Virtual Reality Distraction in Peripheral Intravenous Catheter Insertion to Children From 6 to 11 Years in a Pediatric Day Hospital
- ClinicalTrials.gov ID
- NCT05066061
- Acronym / sponsor ID
- R3VP / AOI 2020 SAVEL
- Keywords
- virtual reality mask, children from 6 to 11, peripheral intravenous catheter insertion, pediatric's day hospital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting difficulties
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 4 Oct 2021 (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.
Main objective :
Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.
Hypothesis :
Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.
Detailed description
Peripheral intravenous catheter insertion is a difficult, painful and anxiety-provoking procedure for hospitalized children, with the possible memorization of pain being even more present for children with chronic pathologies.
Memorization of painful events plays an essential role in anticipating the next experience and can lead to long-term consequences. The child, whose cognitive faculties are gradually developing and whose emotions are very invasive, is particularly concerned by this repercussion.
Different techniques can be used to prevent pain during care (apart from "human" techniques such as comfort, distraction by voice, information on gesture... which are part of good practice).
The national drug safety agency recommends the use of the local anesthetic cream and/or an equimolar mixture of oxygen and nitrous oxide causing surface anesthesia and relaxation and amnesia of the gesture.
Immersion in virtual reality allows to saturate the child's sensorially (3D vision, hearing and kinesthetic proprioception) thus reducing nociceptive perceptions and anxiety. His attention is focused by the virtual animation proposed during this experience. There are many devices (glasses, masks...) as well as various programs more or less specific to care situations, some of them allow to interact with games.
There is no randomized study comparing the efficacy on pain, satisfaction and anxiety of peripheral intravenous catheter insertion with the three possible analgesia techniques: local anesthetic cream / local anesthetic cream and anesthetic and anxiolytic gas / local anesthetic cream and virtual reality mask, nor on the medico-economic impact respecting standard 6 on homogeneous pediatric age groups in clinical trials.
This is a randomized, open-label, three-armed, parallel, single-center therapeutic trial comparing an analgesic strategy using two authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for intravenous catheter insertion in children aged 6 to 11 years old hospitalized in the day hospital of Clermont Ferrand University Hospital.
The control arm is the local anesthetic cream arm, the experimental arms are the local anesthetic cream + anesthetic and anxiolytic gas arm on the one hand and the local anesthetic cream + virtual reality mask type Oculus quest® with interactive program on the other hand.
After informing and obtaining the consent of the child and his parents, will be measured the pain/anxiety/salivary cortisol/heart rate of the child; anxiety of the parents. The nurse evaluates the venous capital of the child then times the time of care and collects (among other things) the number of operators required. Immediately after the treatment, and then 15 to 30 minutes after the insertion will be measured the pain/anxiety/heart rate of the child; anxiety of the parents. The salivary cortisol at 20 minutes after catheter insertion will reflect the stress felt by the child during the procedure. Finally, the satisfaction of the child, parents, nurses will be collected 30 minutes after the care.
After statistical analysis of these three arms, it will be possible to determine the value of the anesthetic and anxiolytic gas and the virtual reality mask to reduce the child's pain and anxiety during the intravenous catheter insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled, open-label, three-arm parallel, single-center therapeutic trial.
| Arm | Type | Receives |
|---|---|---|
| standard | Active comparator | Other: control armOnly use local anesthetic cream |
| anxiolytic gas | Experimental | Other: anxiolytic and analgesic gasUse local anesthetic cream and anesthetic and anxiolytic gas |
| virtual reality | Experimental | Device: Virtual reality maskUse local anesthetic cream and virtual reality mask |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children from 6 to 11 years old requiring an intravenous catheter insertion in a pediatric day hospital at the Clermont Ferrand University Hospital.
- Subjects and their parents who were informed about the study and gave informed consent
- Subjects who have had local anesthetic cream for 1-5 hours at the puncture site
- On the first attempt to apply intravenous catheter on the day of inclusion
- Subjects and their parents able to use the self-report scales proposed in the study.
Key exclusion criteria (9 listed)
- Having a modification of pain's integration (spina bifida for example)
- Having received an analgesic before the care
- Requiring contact isolation
- With a history of seizures or motion sickness
- Born very prematurely (< 28 SA)
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 |
|---|---|---|
| control armusual process | Other | standard |
| anxiolytic and analgesic gasadd relaxing gas | Other | anxiolytic gas |
| Virtual reality maskuse Virtual reality mask Oculus Quest with age-appropriate software | Device | virtual reality |
Primary outcome
change from baseline child's pain at 30 minutes after the care
Time frame: - Before the care - Immediately after the care - 15 to 30 minutes after the care
self-evaluation of children's pain with the visual analog scale in vertical position quote from 0 to 10, 10 represents the worst pain we can feel
5 secondary outcomes
change from baseline child's anxiety at 30 minutes after the care
Time frame: -before the care -immediately after the care -15 to 30 minutes after the care
change from baseline heart rate at 30 minutes after the care
Time frame: -before the care -immediately after the care -15 to 30 minutes after the care
change from baseline salivary cortisol at 30 minutes after the care
Time frame: -before the care -15 to 30 minutes after the care
change from baseline parents' anxiety at 30 minutes after the care
Time frame: -before the care - immediately after the care - 15 to 30 minutes after the care
evaluation of the care with satisfaction questionnaire
Time frame: 30 minutes after the care
Results and safety
The study was stopped early (reason given: recruiting difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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.
EMMANUELLE LABRAISE, NURSE principal investigator
ClermontFerrandUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anxiolytic and analgesic gas and Virtual reality mask in people with Virtual Reality and Catheterization, Peripheral Venous, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 9 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: stopped early, as of the sponsor's last update on 20 Nov 2025. 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 France. 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 was stopped early (reason given: recruiting difficulties). Results are not available in the source record.
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?
change from baseline child's pain at 30 minutes after the care (time frame: - Before the care - Immediately after the care - 15 to 30 minutes after the care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.