Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
VERAPOP
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Oct 2019
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2019
CompletedFirst Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2021
CompletedFebruary 5, 2020
October 1, 2019
1.5 years
October 15, 2019
January 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (4)
the child's anxiety score obtained from the M-Ypass scale
at their arrival in ambulatory service.
the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
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
the child's anxiety score obtained from the M-Ypass scale
at their arrival at the transfer area of the operating room
the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
at the time of induction in the operating room
Study Arms (2)
With animated film
EXPERIMENTALAn 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.
Standard route
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Child boy or girl.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Plateau technique Centre François-Xavier Michelet
Bordeaux, 33000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2019
First Posted
February 5, 2020
Study Start
October 9, 2019
Primary Completion
April 9, 2021
Study Completion
April 9, 2021
Last Updated
February 5, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share