Psychiatric DisordersVEPSYNCT02857322
Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
A study testing Accompanying patient's specific perioperative in people with Psychiatric Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- Accompanying patient's specific perioperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Marilyne Mascarin, 0491381966 ext. +33, drci@ap-hm.fr
About this study
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.
- Conditions
- Psychiatric Disorders
- Being tested
- Accompanying patient's specific perioperative
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accompanying patient's specific perioperativeOther
| Study group | Role | What they receive |
|---|---|---|
| subjects with documented psychiatric pathology | Other | Not described Receives: Other: Accompanying patient's specific perioperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857322
- Sponsor's protocol ID
- 2014-48
- Acronym
- VEPSY
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
- ClinicalTrials.gov ID
- NCT02857322
- Acronym / sponsor ID
- VEPSY / 2014-48
- Conditions
- Psychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with documented psychiatric pathology | Other | Other: Accompanying patient's specific perioperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accompanying patient's specific perioperative | Other | subjects with documented psychiatric pathology |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accompanying patient's specific perioperative in people with Psychiatric Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryline Mascarin (0491382747, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
experiences of the perioperative period (time frame: second day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.