NCT02857322

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

August 5, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

July 29, 2016

Last Update Submit

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

OTHER
Other: Accompanying patient's specific perioperative

Interventions

subjects with documented psychiatric pathology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Maryline Mascarin

CONTACT

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

Locations