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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)

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ClinicalTrials.gov Identifier: NCT04252508
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Anxiety Surgery Pediatric ALL Other: Animated film Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : April 9, 2021
Estimated Study Completion Date : April 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252508


Contacts
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Contact: Marie TRINGALI 05 57 82 00 89 marie.tringali@chu-bordeaux.fr
Contact: Aurore CAPELLI, PhD 05 57 82 08 77 aurore.capelli@chu-bordeaux.fr

Locations
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France
Plateau technique Centre François-Xavier Michelet Recruiting
Bordeaux, France, 33000
Contact: Marie TRINGALI    05 57 82 00 89    marie.tringali@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04252508    
Other Study ID Numbers: CHUBX 2018/57
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Preoperative- Child
Double-reading movie
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders