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Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room (VERAPOP)

U

University Hospital of Bordeaux

Status

Unknown

Conditions

Surgery
Pediatric ALL
Anxiety

Treatments

Other: Animated film

Study type

Interventional

Funder types

Other

Identifiers

NCT04252508
CHUBX 2018/57

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

3 to 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

With animated film
Experimental group
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.
Treatment:
Other: Animated film
Standard route
No Intervention group
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.

Trial contacts and locations

1

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Central trial contact

Aurore CAPELLI, PhD; Marie TRINGALI

Data sourced from clinicaltrials.gov

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