Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.
REVA
1 other identifier
observational
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedAugust 4, 2020
July 1, 2020
11 months
August 1, 2018
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
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
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Lebourdiec
CHI CRETEIL
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