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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Surgery; Pediatric ALL
• Intervention / Treatment: Other: Animated film

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie TRINGALI; Phone Number: 05 57 82 00 89; Email: marie.tringali@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Plateau technique Centre François-Xavier Michelet
    • Contact: Marie TRINGALI; Phone Number: 05 57 82 00 89; Email: marie.tringali@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at their arrival in ambulatory service.
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 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	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.	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.	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.	at the time of induction in the operating room

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Anticipated): April 9, 2021
• Study Completion (Anticipated): April 9, 2021

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Preoperative- Child; Double-reading movie
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CHUBX 2018/57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No