Back to resultsImpact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room (VERAPOP)
Primary Purpose
Anxiety, Surgery, Pediatric ALL
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Animated film
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Preoperative- Child, Double-reading movie
Eligibility Criteria
Inclusion Criteria:
- Child boy or girl.
- 3 to 7 years old.
- programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
- Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
- Accompanied by an adult, French-speaking, whose child lives at home.
- Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child.
- Assent of the child for children aged 6 to 7
- Parents affiliated to social security
For the group under study only:
- Support available at home that can watch the movie on the internet
Exclusion Criteria:
- Child having already had surgery.
- Presence of associated disability (blindness, profound deafness, autistic disorders).
- Child having anxiolytic treatment.
- Child to be operated within less than 2 days
Sites / Locations
- Plateau technique Centre François-Xavier MicheletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
With animated film
Standard route
Arm Description
An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
The information about the surgery will be given by the surgeon during the consultation. Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation.
Outcomes
Primary Outcome Measures
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Secondary Outcome Measures
the child's anxiety score obtained from the M-Ypass scale
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
the child's anxiety score obtained from the M-Ypass scale
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
The EVA-A (Numerical Scale for Anxiety) is a self-assessment scale that assesses situational anxiety.
The question formulated by the professional who makes the welcome interview to the SAS transfer from the operating room to the accompanying person will be the following:
"Can you on a scale of 0 to 10, evaluate your apprehension? " This will allow an estimate of anxiety between 0 and 10. 0 = no anxiety, 10 = maximum anxiety.
Full Information
NCT ID
NCT04252508
First Posted
October 15, 2019
Last Updated
January 30, 2020
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04252508
Brief Title
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
Acronym
VERAPOP
Official Title
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
April 9, 2021 (Anticipated)
Study Completion Date
April 9, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
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
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.
A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Surgery, Pediatric ALL
Keywords
Preoperative- Child, Double-reading movie
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With animated film
Arm Type
Experimental
Arm Description
An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
Arm Title
Standard route
Arm Type
No Intervention
Arm Description
The information about the surgery will be given by the surgeon during the consultation.
Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation.
Intervention Type
Other
Intervention Name(s)
Animated film
Intervention Description
An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
Primary Outcome Measure Information:
Title
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
Description
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Time Frame
The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Secondary Outcome Measure Information:
Title
the child's anxiety score obtained from the M-Ypass scale
Description
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Time Frame
at their arrival in ambulatory service.
Title
the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
Description
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Time Frame
The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Title
the child's anxiety score obtained from the M-Ypass scale
Description
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Time Frame
at their arrival at the transfer area of the operating room
Title
the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
Description
The EVA-A (Numerical Scale for Anxiety) is a self-assessment scale that assesses situational anxiety.
The question formulated by the professional who makes the welcome interview to the SAS transfer from the operating room to the accompanying person will be the following:
"Can you on a scale of 0 to 10, evaluate your apprehension? " This will allow an estimate of anxiety between 0 and 10. 0 = no anxiety, 10 = maximum anxiety.
Time Frame
at the time of induction in the operating room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child boy or girl.
3 to 7 years old.
programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
Accompanied by an adult, French-speaking, whose child lives at home.
Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child.
Assent of the child for children aged 6 to 7
Parents affiliated to social security
For the group under study only:
- Support available at home that can watch the movie on the internet
Exclusion Criteria:
Child having already had surgery.
Presence of associated disability (blindness, profound deafness, autistic disorders).
Child having anxiolytic treatment.
Child to be operated within less than 2 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie TRINGALI
Phone
05 57 82 00 89
Email
marie.tringali@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurore CAPELLI, PhD
Phone
05 57 82 08 77
Email
aurore.capelli@chu-bordeaux.fr
Facility Information:
Facility Name
Plateau technique Centre François-Xavier Michelet
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie TRINGALI
Phone
05 57 82 00 89
Email
marie.tringali@chu-bordeaux.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
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