Clinical trial NCT04252508: Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
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
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Surgery
Pediatric ALL
Keywords: Preoperative- Child
Double-reading movie
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
timeFrame: 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:
measure: the child's anxiety score obtained from the M-Ypass scale
timeFrame: at their arrival in ambulatory service.
measure: the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
timeFrame: 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
measure: the child's anxiety score obtained from the M-Ypass scale
timeFrame: at their arrival at the transfer area of the operating room
measure: the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
timeFrame: at the time of induction in the operating room
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Plateau technique Centre François-Xavier Michelet
Study officials:
References: