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

NCT ID: NCT04252508

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2021-04-09

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.

Conditions

Anxiety; Surgery; Pediatric ALL

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

With animated film

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.

Group Type: EXPERIMENTAL

Animated film

Intervention Type: OTHER

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.

Standard route

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Animated film

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Plateau technique Centre François-Xavier Michelet

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marie TRINGALI

Role: CONTACT

marie.tringali@chu-bordeaux.fr

05 57 82 00 89

Aurore CAPELLI, PhD

Role: CONTACT

aurore.capelli@chu-bordeaux.fr

05 57 82 08 77

Facility Contacts

Marie TRINGALI

Role: primary

marie.tringali@chu-bordeaux.fr

05 57 82 00 89

Other Identifiers

CHUBX 2018/57

Identifier Type: -

Identifier Source: org_study_id