NCT03651999

Brief Summary

A "dream workshop" is organized for the children by nurses specialized in anesthesia in the CHI Creteil. During this workshop, the anesthesia process is explained to the children using games, drawings, songs, etc. The impact of this workshop on the child stress and acceptance of the mask during induction is studied in this research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

August 1, 2018

Last Update Submit

July 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptance or not acceptance of the mask in the operating room

    evaluated by the operating nurse

    day of planned surgery

Secondary Outcomes (6)

  • Paediatric Anaesthesia Emergence Delirium score

    day of planned surgery

  • Yale Preoperative Anxiety Scale

    day of planned surgery

  • Visual analogic anxiety score

    day of planned surgery

  • Face Legs Activity Cry Consolability

    1h post planned surgery

  • Post Hospitalization Behavior Questionnaire

    day 1 post planned surgery

  • +1 more secondary outcomes

Study Arms (2)

dream workshop

After consultation with the pediatric surgeon or the anesthesiologist, parents and children are invited to meet the nurse anesthetist, in a room dedicated to this purpose and specially designed to accommodate children; they will find a playmobil model, photographs of the patient circuit as well as different games or activities that can be performed during induction; The nurse anesthetist explains the hospitalization process and will help them to choose a pleasant dream, a perfume adapted to their taste, a distraction adapted to their age (animated book, soap bubbles, favorite song ...); the child will be able to customize his mask and choose the blanket he wants to take along; the most recalcitrant or special sites (autism, long-term hospitalization) will be able to be accompanied by a parent during sleep

Other: participation in a workshop: "dream workshop" animated by a nurse anesthesist

control

No "dream workshop"

Interventions

After consultation with the pediatric surgeon or the anesthesiologist, parents and children are invited to meet the nurse, in a room dedicated to this purpose and specially designed to accommodate children; they will find a playmobil model, photographs of the patient circuit as well as different games or activities that can be performed during induction; the nurse anesthetist will take care to explain to them the progress of the hospitalization and help them to choose a pleasant dream, a perfume adapted to their taste, a distraction adapted to their age (animated book, soap bubbles, favorite song ...) ; he can customize his mask and choose the blanket he wants to take; the most recalcitrant or special sites (autism, long-term hospitalization) will be able to be accompanied by a parent during sleep

dream workshop

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children from 3 to 8 years old planned ambulatory surgery

You may qualify if:

  • Children who need an ambulatory surgery
  • benefiting from a health care insurance

You may not qualify if:

  • surgery planned in another hospital
  • hospitalized children
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHi Creteil

Créteil, 94000, France

Location

Study Officials

  • Sophie Lebourdiec

    CHI CRETEIL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 29, 2018

Study Start

December 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations