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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2020
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHi Creteil Créteil

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

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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