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TerminatedNCT05066061R3VPUpdated Nov 20, 2025

Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP)

An interventional study of control arm and anxiolytic and analgesic gas in Virtual Reality, Catheterization, Peripheral Venous and Children, Only, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention

Why this study was terminated
recruiting difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Virtual Reality
  • Catheterization, Peripheral Venous
  • Children, Only
  • Pain, Procedural

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Keywords

  • virtual reality mask
  • children from 6 to 11
  • peripheral intravenous catheter insertion
  • pediatric's day hospital
03

In context

Pain, Procedural

237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 223 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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)
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    standard

    Only use local anesthetic cream

    Other: control arm

  • Experimental
    anxiolytic gas

    Use local anesthetic cream and anesthetic and anxiolytic gas

    Other: anxiolytic and analgesic gas

  • Experimental
    virtual reality

    Use local anesthetic cream and virtual reality mask

    Device: Virtual reality mask

Interventions

  • Othercontrol arm

    usual process

  • Otheranxiolytic and analgesic gas

    add relaxing gas

  • DeviceVirtual reality mask

    use Virtual reality mask Oculus Quest with age-appropriate software

06

What researchers measure

Primary outcomes

  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

    Time frame: - Before the care - Immediately after the care - 15 to 30 minutes after the care

Secondary outcomes

  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)

    Time frame: -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)

    Time frame: -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

    Time frame: -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)

    Time frame: -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)

    Time frame: 30 minutes after the care

07

Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05066061
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Oct 4, 2021
Start date
Dec 6, 2021
Primary completion
Nov 3, 2025
Completion
Nov 3, 2025
Last update
Nov 20, 2025

Study contacts

EMMANUELLE LABRAISE, NURSE
principal investigator · ClermontFerrandUH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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