Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children (REVAPRICK)
Primary Purpose
Virtual Reality, Testicular Diseases, Children, Only
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality mask
control arm
Sponsored by
About this trial
This is an interventional prevention trial for Virtual Reality focused on measuring virtual reality mask, children from 7 to 13, allergic pricks tests, consultation and pediatric's day hospital
Eligibility Criteria
Inclusion Criteria:
- Children from 7 to 13 years old requiring blood test and prick tests in pediatric consultation at the Clermont-Ferrand University Hospital and in the pediatric's day hospital at the Saint-Etienne University Hospital
- Subjects and their parents who were informed about the study and gave informed consent
- Enrollment in the Social Security system
- Children and parents able to use the self-report scales proposed in the study
Exclusion Criteria:
Children from 7 to 13 :
- presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post-traumatic stress disorder)
- 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
- Refusal of the parents and/or the child
Sites / Locations
- CHU de Clermont-Ferrand
- CHU de Saint Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard
virtual reality
Arm Description
Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas
Use local anesthesic cream and virtual reality mask
Outcomes
Primary Outcome Measures
children's pain hetero-evaluation
children's pain evaluation by the nurse with the visual analog scale quote from 0 to 10, 10=worst score
children's pain hetero-evaluation
children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score
children's pain self-evaluation
self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score
Secondary Outcome Measures
change from baseline children's anxiety at just after the care
self-evaluation of children's anxiety with the scale "child fear scale" quote from 0 to 4, 4= worst score
children's anxiety hetero evaluation
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
children's anxiety hetero evaluation
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
change from baseline parents' anxiety at just after the care
self-evaluation of parents' anxiety with the numerical scale quote from 1 to 10, 10= worst score
evaluation of the care
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 with a score from 1 to 5 (5= best score, very satisfied) and for nurse with a score from 1 to 5 (5= best score, very satisfied)
Full Information
NCT ID
NCT05378581
First Posted
May 2, 2022
Last Updated
May 16, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT05378581
Brief Title
Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children
Acronym
REVAPRICK
Official Title
Evaluation of the Use of a Virtual Reality Mask During Blood Tests and Prick Tests Performed in Allergic Children Aged 7 to 13 Years: a Multicenter, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (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 blood test and pricks tests in allergic children aged from 7 to 13 years.
Hypothesis :
Using virtual reality mask during blood test and pricks tests for allergic kids from 7 to 13 would reduce anxiety and pain
Detailed Description
Investigation of food or respiratory allergy is based on prick tests and serum specific immunoglobulin E assays. The nurse often controls the blood test pain but during the skin tests, many children cry, feeling both fear and pain. This traumatic experience will in most cases be repeated during the child's allergic follow-up.
To date, there are few effective means of limiting anxiety and pain associated with prick tests and therefore little research work on this subject.
Immersion in virtual reality (VR) seems to be an interesting way of distraction for children from 7 to 13 years needing this treatment. Indeed, it makes it possible to saturate the sensorially of the child thus reducing the nociceptive perceptions and the anxiety. The choice of VR mask with pediatric program specific seems interesting for this children This is a randomized, open-label, two-armed parallel, multicenter therapeutic trial comparing an analgesic strategy using authorized medical devices (conventional strategy) with a virtual reality mask distraction technique for allergics tests in children from 7 to 13 years old hospitalized in the pediatric consultation of Clermont Ferrand University Hospital and in the day hospital of Saint-Etienne University Hospital
The control arm is the local anesthetic cream (for the blood test) arm with distraction from nurse/parents +/-anesthesic and anxiolytic gas and the experimental arm is the local anesthetic cream + virtual reality mask distraction
The nurse informs and obtains the consent of the child and his parents. Then she measures child's pain and anxiety before the care, during the blood test, at the third prick test and immediately after the care.
She also notes the anxiety of the parents before and after the care. Finally, the satisfaction of the child, parents, nurses will be collected at the end of the care.
After statistical analysis of these two arms, it will be possible to determine the value of the virtual reality mask to reduce the child's pain and anxiety during the pricks tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Testicular Diseases, Children, Only, Pain, Procedural, Anxiety and Fear
Keywords
virtual reality mask, children from 7 to 13, allergic pricks tests, consultation and 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, two arms parallel, multicenter therapeutic trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard
Arm Type
Active Comparator
Arm Description
Use local anesthesic cream + nurse or parents distraction +/- anesthesic or anxiolytic gas
Arm Title
virtual reality
Arm Type
Experimental
Arm Description
Use local anesthesic cream and virtual reality mask
Intervention Type
Device
Intervention Name(s)
Virtual reality mask
Intervention Description
virtual reality mask Deepsen® with age-appropriate software Birdy®
Intervention Type
Other
Intervention Name(s)
control arm
Intervention Description
usual process
Primary Outcome Measure Information:
Title
children's pain hetero-evaluation
Description
children's pain evaluation by the nurse with the visual analog scale quote from 0 to 10, 10=worst score
Time Frame
during blood test
Title
children's pain hetero-evaluation
Description
children's pain evaluation by the nurse with the visual analog scale from 0 to 10, 10= worst score
Time Frame
during procedure (prick test)
Title
children's pain self-evaluation
Description
self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score
Time Frame
5 min after the care
Secondary Outcome Measure Information:
Title
change from baseline children's anxiety at just after the care
Description
self-evaluation of children's anxiety with the scale "child fear scale" quote from 0 to 4, 4= worst score
Time Frame
before the care and 5 min after the care
Title
children's anxiety hetero evaluation
Description
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
Time Frame
during blood test
Title
children's anxiety hetero evaluation
Description
children's anxiety evaluation by the nurse with the scale "child fear scale" quote from 0 to 4, 4= worst score
Time Frame
during procedure (prick tests)
Title
change from baseline parents' anxiety at just after the care
Description
self-evaluation of parents' anxiety with the numerical scale quote from 1 to 10, 10= worst score
Time Frame
before the care and 5 min after the care
Title
evaluation of the care
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 with a score from 1 to 5 (5= best score, very satisfied) and for nurse with a score from 1 to 5 (5= best score, very satisfied)
Time Frame
5 min after the care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children from 7 to 13 years old requiring blood test and prick tests in pediatric consultation at the Clermont-Ferrand University Hospital and in the pediatric's day hospital at the Saint-Etienne University Hospital
Subjects and their parents who were informed about the study and gave informed consent
Enrollment in the Social Security system
Children and parents able to use the self-report scales proposed in the study
Exclusion Criteria:
Children from 7 to 13 :
presenting a contraindication to the use of the virtual reality mask: heart disease, epilepsy, psychiatric illness (major anxiety, post-traumatic stress disorder)
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
Refusal of the parents and/or the child
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra USCLADE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
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
Facility Name
CHU de Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42000
Country
France
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
Christine REDURON
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children
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