Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
VEPSY
1 other identifier
interventional
88
1 country
1
Brief Summary
The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedAugust 5, 2016
July 1, 2016
3 years
July 29, 2016
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
experiences of the perioperative period
assessment using a self-administered questionnaire called EVAN. This is a standardized questionnaire and validated, whose purpose is to understand the experience of perioperative anesthesia multidimensional way. It contains 28 items describing 6 dimensions (anxiety, discomfort, fear, pain and discomfort, explanations, needs). dimensional scores range from 0 (worst experience) to 100 (best experience).
second day
Study Arms (1)
subjects with documented psychiatric pathology
OTHERInterventions
Eligibility Criteria
You may qualify if:
- adult subject;
- Subject with chronic mental illness defined by ICD-10 classification \[ICD-10, 1992\], corresponding to psychoses say no emotional or affective psychoses say;
- Subject to which mental pathology is evolving for more than 6 months;
- Topic targeted for elective surgery;
- Topic judged capable of performing a self-administered questionnaire;
You may not qualify if:
- minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship;
- Subject to benefit from surgery as part of the emergency;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Urielle DESALBRES
Assistance Publique Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 5, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2020
Study Completion
May 1, 2020
Last Updated
August 5, 2016
Record last verified: 2016-07