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

Primary Purpose

Virtual Reality, Catheterization, Peripheral Venous, Children, Only

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
control arm
anxiolytic and analgesic gas
Virtual reality mask
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Virtual Reality focused on measuring virtual reality mask, children from 6 to 11, peripheral intravenous catheter insertion, pediatric's day hospital

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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:

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)

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

standard

anxiolytic gas

virtual reality

Arm Description

Only use local anesthetic cream

Use local anesthetic cream and anesthetic and anxiolytic gas

Use local anesthetic cream and virtual reality mask

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
change from baseline heart rate at 30 minutes after the care
- Measure of heart rate (number of heartbeats in one minute)
change from baseline salivary cortisol at 30 minutes after the care
- salivary cortisol : results in µg/l
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)
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)

Full Information

First Posted
September 6, 2021
Last Updated
May 2, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05066061
Brief Title
Virtual Reality and Peripheral Intravenous Catheter Insertion to Children (R3VP)
Acronym
R3VP
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, open-label, three-arm parallel, single-center therapeutic trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard
Arm Type
Active Comparator
Arm Description
Only use local anesthetic cream
Arm Title
anxiolytic gas
Arm Type
Experimental
Arm Description
Use local anesthetic cream and anesthetic and anxiolytic gas
Arm Title
virtual reality
Arm Type
Experimental
Arm Description
Use local anesthetic cream and virtual reality mask
Intervention Type
Other
Intervention Name(s)
control arm
Intervention Description
usual process
Intervention Type
Other
Intervention Name(s)
anxiolytic and analgesic gas
Intervention Description
add relaxing gas
Intervention Type
Device
Intervention Name(s)
Virtual reality mask
Intervention Description
use Virtual reality mask Oculus Quest with age-appropriate software
Primary Outcome Measure Information:
Title
change from baseline child's pain at 30 minutes after the care
Description
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 Outcome Measure Information:
Title
change from baseline child's anxiety at 30 minutes after the care
Description
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
Title
change from baseline heart rate at 30 minutes after the care
Description
- 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
Title
change from baseline salivary cortisol at 30 minutes after the care
Description
- salivary cortisol : results in µg/l
Time Frame
-before the care -15 to 30 minutes after the care
Title
change from baseline parents' anxiety at 30 minutes after the care
Description
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
Title
evaluation of the care with satisfaction questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMMANUELLE LABRAISE, NURSE
Organizational Affiliation
ClermontFerrandUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Labraise

12. IPD Sharing Statement

Plan to Share IPD
No

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

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