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Completed

NCT Number: NCT04252508

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Surgery

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plateau technique Centre François-Xavier Michelet

Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animated film

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.

Primary outcomes

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

    Time frame: 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

    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.

Secondary outcomes

  1. the child's anxiety score obtained from the M-Ypass scale

    Time frame: at 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.

  2. the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service

    Time frame: 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

    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.

  3. the child's anxiety score obtained from the M-Ypass scale

    Time frame: at their arrival at the transfer area of the operating room

    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.

  4. the child's anxiety score obtained from the EVA-A for the parent/legal guardian.

    Time frame: at the time of induction in the operating room

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: VERAPOP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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