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

NCT05066061 | Terminated

• 2 other identifiers: AOI 2020 SAVEL2020-A03229-30
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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

  - 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

  -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

  -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

  -before the care -15 to 30 minutes after the care

• change from baseline parents' anxiety at 30 minutes after the care

  -before the care - immediately after the care - 15 to 30 minutes after the care

• evaluation of the care with satisfaction questionnaire

  30 minutes after the care

Study Arms (3)

standard

ACTIVE COMPARATOR

Only use local anesthetic cream

Other: control arm

anxiolytic gas

EXPERIMENTAL

Use local anesthetic cream and anesthetic and anxiolytic gas

Other: anxiolytic and analgesic gas

virtual reality

EXPERIMENTAL

Use local anesthetic cream and virtual reality mask

Device: Virtual reality mask

Interventions

control arm OTHER

usual process

standard

anxiolytic and analgesic gas OTHER

add relaxing gas

anxiolytic gas

Virtual reality mask DEVICE

use Virtual reality mask Oculus Quest with age-appropriate software

virtual reality

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Subjects and their parents able to use the self-report scales proposed in the study.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Anti-Anxiety Agents

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• EMMANUELLE LABRAISE, NURSE

  ClermontFerrandUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, open-label, three-arm parallel, single-center therapeutic trial.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 4, 2021
• Study Start: December 6, 2021
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)