COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative (VEPSY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02857322
Recruitment Status : Unknown
Verified July 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Not yet recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Psychiatric Disorders Other: Accompanying patient's specific perioperative Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
subjects with documented psychiatric pathology Other: Accompanying patient's specific perioperative


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. experiences of the perioperative period [ Time Frame: second day ]
    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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship;
  • Subject with a mental illness do not belong to sections of ICD-10 contained in "inclusion criteria";
  • Subject to benefit from surgery as part of the emergency;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857322


Contacts
Layout table for location contacts
Contact: Maryline Mascarin 0491382747 drci@ap-hm.fr

Locations
Layout table for location information
France
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354
Contact: Marilyne Mascarin    0491381966 ext +33    drci@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02857322    
Other Study ID Numbers: 2014-48
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Mental Disorders
Problem Behavior
Behavioral Symptoms