AzTrials
AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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
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.

France1 site
  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

Other trials in France

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 groups in NCT05066061
Study groupRoleWhat they receive
standardActive comparatorOnly use local anesthetic cream
Receives: Other: control arm
anxiolytic gasExperimentalUse local anesthetic cream and anesthetic and anxiolytic gas
Receives: Other: anxiolytic and analgesic gas
virtual realityExperimentalUse 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted4 Oct 2021
  2. Study start6 Dec 2021
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Why it stopped: recruiting difficulties

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in