- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03651999
Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room. (REVA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For more than two years, nurse anesthetists have developed a personalized treatment of children who will be asleep using the theoretical bases of hypnosis in children and distraction, in order to improve the conditions of falling asleep, especially by promoting the acceptance of the mask during inhalation induction, or by preparing it for an Intra Venous induction, if it so desires or if it is obligatory.
Indeed, the announcement of a surgical intervention is sometimes experienced as a real emotional shock by the parents and / or the child, whatever the gravity or the stake of the surgical gesture. To all this is added the phobic fear of anesthesia and all conditions are met to generate a climate of maximum stress. The work of nurse anesthesists prior to this surgical procedure was to establish a relationship of trust with the child through this "dream workshop", to restore a more serene climate.
Thus, is it the idea of this "workshop of the dream", allowing thanks to the imagination of the child, to recreate a universe of confidence full of colors, songs and perfume ...
After consultation with the pediatric surgeon or the anesthesiologist, parents and children are invited to meet nurse anesthesists, if they wish, 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Créteil, France, 94000
- CHI Créteil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
|
control
No "dream workshop"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance or not acceptance of the mask in the operating room
Time Frame: day of planned surgery
|
evaluated by the operating nurse
|
day of planned surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paediatric Anaesthesia Emergence Delirium score
Time Frame: day of planned surgery
|
day of planned surgery
|
|
Yale Preoperative Anxiety Scale
Time Frame: day of planned surgery
|
day of planned surgery
|
|
Visual analogic anxiety score
Time Frame: day of planned surgery
|
on a 0 to 10 scale
|
day of planned surgery
|
Face Legs Activity Cry Consolability
Time Frame: 1h post planned surgery
|
post-surgery pain in the recovery room
|
1h post planned surgery
|
Post Hospitalization Behavior Questionnaire
Time Frame: day 1 post planned surgery
|
day 1 post planned surgery
|
|
Post Hospitalization Behavior Questionnaire
Time Frame: day 7 post planned surgery
|
day 7 post planned surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sophie Lebourdiec, CHI Créteil
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REVA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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