Anesthesia Clinical Trial
— REVAOfficial title:
Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.
NCT number | NCT03651999 |
Other study ID # | REVA |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2017 |
Est. completion date | November 1, 2019 |
Verified date | July 2020 |
Source | Centre Hospitalier Intercommunal Creteil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 3 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Children who need an ambulatory surgery - benefiting from a health care insurance Exclusion Criteria: - surgery planned in another hospital - hospitalized children - refusal to participate |
Country | Name | City | State |
---|---|---|---|
France | CHi Creteil | Créteil |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Intercommunal Creteil |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptance or not acceptance of the mask in the operating room | evaluated by the operating nurse | day of planned surgery | |
Secondary | Paediatric Anaesthesia Emergence Delirium score | day of planned surgery | ||
Secondary | Yale Preoperative Anxiety Scale | day of planned surgery | ||
Secondary | Visual analogic anxiety score | on a 0 to 10 scale | day of planned surgery | |
Secondary | Face Legs Activity Cry Consolability | post-surgery pain in the recovery room | 1h post planned surgery | |
Secondary | Post Hospitalization Behavior Questionnaire | day 1 post planned surgery | ||
Secondary | Post Hospitalization Behavior Questionnaire | day 7 post planned surgery |
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