VEPSY: Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT02857322
Collaborator
(none)
88
1
1
40
2.2

Study Details

Study Description

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
  • Other: Accompanying patient's specific perioperative
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: subjects with documented psychiatric pathology

Other: Accompanying patient's specific perioperative

Outcome Measures

Primary Outcome Measures

  1. experiences of the perioperative period [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Assistance Publique Hôpitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle DESALBRES, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02857322
Other Study ID Numbers:
  • 2014-48
First Posted:
Aug 5, 2016
Last Update Posted:
Aug 5, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2016