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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

Tracking Information
First Submitted Date  ICMJE October 15, 2019
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
Official Title  ICMJE Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Anxiety
  • Surgery
  • Pediatric ALL
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Animated film
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 9, 2021
Estimated Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252508
Other Study ID Numbers  ICMJE CHUBX 2018/57
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bordeaux
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP