Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

Psychiatric Disorders Clinical Trial

— VEPSY  

Official title:

Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02857322
• Other study ID #: 2014-48
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 2, 2016
• Start date: January 2017
• Est. completion date: May 2020

Study information

• Verified date: July 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Maryline Mascarin
• Phone: 0491382747
• Email: drci[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: May 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorders

Intervention

Other:
• Accompanying patient's specific perioperative

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No