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

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ClinicalTrials.gov Identifier: NCT02857322
Recruitment Status : 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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
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

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



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).



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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;

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
Contact: Maryline Mascarin 0491382747 drci@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Marilyne Mascarin    0491381966 ext +33    drci@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02857322     History of Changes
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:
Mental Disorders
Problem Behavior
Behavioral Symptoms