Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252508
Acronym
VERAPOP
Enrollment
80
Registered
2020-02-05
Start date
2019-10-09
Completion date
2022-05-02
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pediatric ALL, Surgery

Keywords

Preoperative- Child, Double-reading movie

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.

Interventions

OTHERAnimated 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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.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 studyEvaluation 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.

Secondary

MeasureTime frameDescription
the child's anxiety score obtained from the M-Ypass scaleat their arrival in ambulatory service.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 child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory serviceThe 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 studyEvaluation 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 child's anxiety score obtained from the EVA-A for the parent/legal guardian.at the time of induction in the operating roomThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026