Satisfaction, PersonalPEPPERNCT03521453
PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot
An observational study of Satisfaction, Personal and Anesthesia, run by University Hospital, Angers at 1 site in France.
Trial summary
Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit, patients should be informed of the different available technics of anesthesia (i.e. general or loco-regional) and of their own risks . Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Satisfaction, Personal, Anesthesia
- What is being tested?
- PEPPER robot
- How many people
- 298 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2018to 15 Jun 2018
- Phase
- Observational
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients scheduled for a pre-Anesthesia visit during the study period (for orthopedic, general, urologic, ophthalmologic surgeries or for endoscopic examination under anesthesia).
Who may be able to join
- Adult patients scheduled for a pre-Anesthesia visit during the study period
Who cannot join
- Refusal to answer the questionnaire
- unable to answer the questionnaire (not speaking french...)
Trial locations and contacts
1 site in 1 country.
About this study
Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit, patients should be informed of the different available technics of anesthesia (i.e. general or loco-regional) and of their own risks .
Nowadays, many informations are given through written paper and leaflets, just before the consultation. In addition, patients need usually to wait for the doctor. This time may be used to give information, and new information's support, such as videos, may be used.
The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients and to give informations, may increase the satisfaction of patients having a pre anesthesia visit for a scheduled surgery.
Read the detailed description
Before- after observational study.
All adult patients (age≥18 yrs) coming for a pre-anesthesia visit will be proposed to fulfill a questionnaire regarding their satisfaction and the quality of information they received.
- in the first period, patients will receive paper informations before the anesthesia visit.
- in the second period, they will have the same paper informations but a robot PEPPER will also stand in the waiting room and propose to the patients to give them informations about anesthesia, patients journey, risks, blood transfusion etc...
- Conditions
- Satisfaction, Personal, Anesthesia
- Being tested
- PEPPER robot
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEPPER robotOther
Presence of a Robot (PEPPER Robot), designed and programmed to give informations, using a screen and vocal. All the patients in the second period will have access to,the robot, while waiting for the visit.
| Study group | Role | What they receive |
|---|---|---|
| Before | Conventionnel written information | |
| After, with PEPPER | Written information + presence of a robot (PEPPER) in the waiting room, who will give informations. Receives: Other: PEPPER robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients satisfaction about the pre-anesthesia visit
numerical scale from 0 to 10 (poor to excellent)
Measured: 1 hour
Secondary outcomes (3)
quality of information
numerical scale from 0 to 10 (poor to excellent)
Measured: 1 hour
quality of information about risks
numerical scale from 0 to 10 (poor to excellent)
Measured: 1 hour
annoying of waiting
numerical scale from 0 to 10 (none to maximal)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 Apr 2018
- Primary completion30 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PersonalStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- sigismond Lasocki, MD, PhD, Study chair, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521453
- Sponsor's protocol ID
- PEPPER-01
- Acronym
- PEPPER
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEPPER : PErcePtion of Pre-anesthesia Visit With or Without Robot
- ClinicalTrials.gov ID
- NCT03521453
- Acronym / sponsor ID
- PEPPER / PEPPER-01
- Conditions
- Satisfaction, Personal, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 11 May 2018 (actual)
- 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.
Pre-anesthesia visit for scheduled surgery is mandatory by law in France. During this visit, patients should be informed of the different available technics of anesthesia (i.e. general or loco-regional) and of their own risks .
Nowadays, many informations are given through written paper and leaflets, just before the consultation. In addition, patients need usually to wait for the doctor. This time may be used to give information, and new information's support, such as videos, may be used.
The aim of this study is to evaluated if a robot (PEPPER), who is able to answer to patients and to give informations, may increase the satisfaction of patients having a pre anesthesia visit for a scheduled surgery.
Detailed description
Before- after observational study.
All adult patients (age≥18 yrs) coming for a pre-anesthesia visit will be proposed to fulfill a questionnaire regarding their satisfaction and the quality of information they received.
- in the first period, patients will receive paper informations before the anesthesia visit.
- in the second period, they will have the same paper informations but a robot PEPPER will also stand in the waiting room and propose to the patients to give them informations about anesthesia, patients journey, risks, blood transfusion etc...
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | –Conventionnel written information |
| After, with PEPPER | – | Other: PEPPER robotWritten information + presence of a robot (PEPPER) in the waiting room, who will give informations. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients scheduled for a pre-Anesthesia visit during the study period (for orthopedic, general, urologic, ophthalmologic surgeries or for endoscopic examination under anesthesia).
Key inclusion criteria (1 listed)
- Adult patients scheduled for a pre-Anesthesia visit during the study period
Key exclusion criteria (2 listed)
- Refusal to answer the questionnaire
- unable to answer the questionnaire (not speaking french...)
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 |
|---|---|---|
| PEPPER robotPresence of a Robot (PEPPER Robot), designed and programmed to give informations, using a screen and vocal. All the patients in the second period will have access to,the robot, while waiting for the visit. | Other | After, with PEPPER |
Primary outcome
Patients satisfaction about the pre-anesthesia visit
Time frame: 1 hour
numerical scale from 0 to 10 (poor to excellent)
3 secondary outcomes
quality of information
Time frame: 1 hour
quality of information about risks
Time frame: 1 hour
annoying of waiting
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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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.
sigismond Lasocki, MD, PhD study chair
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Personal and Anesthesia, run by University Hospital, Angers 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients satisfaction about the pre-anesthesia visit (time frame: 1 hour). 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 17 Nov 2020.