AnesthesiaREVANCT03651999
Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.
An observational study of Anesthesia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- participation in a workshop: "dream workshop" animated by a nurse anesthesist
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Child
Study population: children from 3 to 8 years old planned ambulatory surgery
Who may be able to join
- Children who need an ambulatory surgery
- benefiting from a health care insurance
Who cannot join
- surgery planned in another hospital
- hospitalized children
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- participation in a workshop: "dream workshop" animated by a nurse anesthesist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participation in a workshop: "dream workshop" animated by a nurse anesthesistOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: participation in a workshop: "dream workshop" animated by a nurse anesthesist | |
| control | No "dream workshop" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance or not acceptance of the mask in the operating room
evaluated by the operating nurse
Measured: day of planned surgery
Secondary outcomes (6)
Paediatric Anaesthesia Emergence Delirium score
Measured: day of planned surgery
Yale Preoperative Anxiety Scale
Measured: day of planned surgery
Visual analogic anxiety score
on a 0 to 10 scale
Measured: day of planned surgery
Face Legs Activity Cry Consolability
post-surgery pain in the recovery room
Measured: 1h post planned surgery
Post Hospitalization Behavior Questionnaire
Measured: day 1 post planned surgery
Post Hospitalization Behavior Questionnaire
Measured: day 7 post planned surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Dec 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Lebourdiec, Principal investigator, CHI CRETEIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651999
- Sponsor's protocol ID
- REVA
- Acronym
- REVA
- Status last verified
- Jul 2020
- First submitted
- 1 Aug 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.
- ClinicalTrials.gov ID
- NCT03651999
- Acronym / sponsor ID
- REVA / REVA
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dream workshop | – | Other: participation in a workshop: "dream workshop" animated by a nurse anesthesistAfter 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" |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- children from 3 to 8 years old planned ambulatory surgery
Key inclusion criteria (2 listed)
- Children who need an ambulatory surgery
- benefiting from a health care insurance
Key exclusion criteria (3 listed)
- surgery planned in another hospital
- hospitalized children
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| participation in a workshop: "dream workshop" animated by a nurse anesthesistAfter 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 | Other | dream workshop |
Primary outcome
Acceptance or not acceptance of the mask in the operating room
Time frame: day of planned surgery
evaluated by the operating nurse
6 secondary outcomes
Paediatric Anaesthesia Emergence Delirium score
Time frame: day of planned surgery
Yale Preoperative Anxiety Scale
Time frame: day of planned surgery
Visual analogic anxiety score
Time frame: day of planned surgery
Face Legs Activity Cry Consolability
Time frame: 1h post planned surgery
Post Hospitalization Behavior Questionnaire
Time frame: day 1 post planned surgery
Post Hospitalization Behavior Questionnaire
Time frame: day 7 post planned surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Lebourdiec principal investigator
CHI CRETEIL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance or not acceptance of the mask in the operating room (time frame: day of planned surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.